Regulatory Procedures Manual Food And Drug

Summary

Regulatory Procedures Manual
Chapter 7: RECALL PROCEDURES
This chapter contains the following sections:
Section Topic Page
7-1 PURPOSE ............................................................................................................. 4
7-2 BACKGROUND ..................................................................................................... 4
7-3 SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES .......................... 5
7-3-1 Responsibilities of the Office of Strategic Planning and Operational
Policy/Division of Enforcement/Recall Operations Branch (OSPOP/DE/ROB) ............ 6
7-3-2 Responsibilities and Procedures – ORA/Office of Partnerships and
Operational Policy (OPOP) .......................................................................................... 6
7-3-3 Responsibilities and Procedures – Office of Information Systems
Management/ Division of System Solutions (DSS) /Enforcement Systems Branch ..... 6
7-4 RECALL ENTERPRISE SYSTEM ......................................................................... 6
7-4-1 Enforcement Report ........................................................................................ 7
7-5 INITIATION OF A RECALL .................................................................................... 7
7-5-1 Firm Initiated Recalls ...................................................................................... 8
7-5-2 FDA Requested Recall ................................................................................. 13
7-5-3 FDA Mandated and Ordered Recalls ............................................................ 14
7-5-4 Removals and corrections involving products exported from the U.S. and
products imported to the U.S. .................................................................................... 18
7-6 RECALL CLASSIFICATION AND STRATEGY .................................................... 22
7-6-1 Health Hazard Evaluation ............................................................................. 22
7-6-2 Classification Process ................................................................................... 23
7-6-3 Recall Strategy.............................................................................................. 24
7-7 NOTIFICATIONS AND PUBLIC WARNING ........................................................ 25
7-7-1 Reports and Reporting Procedures............................................................... 25
7-7-2 Notification to Other Government Agencies .................................................. 28
7-7-3 Public Warning .............................................................................................. 30
7-8 RECALL MONITORING....................................................................................... 33
7-8-1 Background ................................................................................................... 33
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7-8-2 Managing FDA’s Recall Audit Check (RAC) Strategy ................................... 33
7-8-3 Requesting and Reviewing Recall Status Reports Requesting and Reviewing
Recall Status Reports ................................................................................................ 40
7-8-4 State Audits .................................................................................................. 40
7-9 RECALL TERMINATION ..................................................................................... 41
7-10 ATTACHMENTS, EXHIBITS, AND APPENDIX ................................................... 42
ATTACHMENTS: ....................................................................................................... 43
EXHIBITS: ................................................................................................................. 44
APPENDIX: ............................................................................................................... 45
Attachment A – Recall Alert Information .................................................................... 46
Attachment B – Recommendation for Recall Classification ....................................... 48
Attachment B1 – Recommendation for Recall Classification and Termination .......... 53
Attachment C – Recall Termination or Recommendation for Termination ................. 54
Attachment D – Health Hazard Evaluation Worksheet .............................................. 55
Attachment D1 – 21 CFR Part 7, Guidance to Health Hazard Evaluation Committees

...................................................................................................................... 58
Attachment E – Recalls Of Radiation Emitting Electronic Products Under Subchapter
C - Electronic Product Radiation Control Of Chapter V Of The Federal Food, Drug,
And Cosmetic Act (The Act), Formerly The Radiation Control For Health And Safety
Act Of 1968 (RCHSA) ................................................................................................ 62
Attachment F – Recalls of Infant Formula.................................................................. 66
Attachment G – Recalls of Medical Devices, Section 518(e) ..................................... 67
Attachment H – Methods for Conducting Recall Effectiveness Checks ..................... 72
Attachment I – Mandatory Recall of Tobacco Products ............................................. 74
Attachment J – Mandatory Recall Authority for Foods ............................................... 76
Attachment J1 – Recommendation Memorandum ..................................................... 88
Attachment J2 – Notification of Opportunity to Initiatiate a Voluntary Recall ............. 89
Attachment J3 – Prehearing Order to Cease Distribution and Give Notice................ 91
Attachment J4 – Denial of Hearing Request .............................................................. 93
Attachment J5 – Hearing Report Cover Letter ........................................................... 94
Attachment J6 – Hearing Report................................................................................ 95
Attachment J7 – Vacated Order ................................................................................ 96
Attachment J8 – Amended Order .............................................................................. 97
Attachment J9 – Modified Order ................................................................................ 98
Attachment J10 – Mandatory Food Recall Process Flow Chart................................. 99
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Attachment K – Notification, Nondistribution, and Recall of Controlled Substances for
Human or Animal Use.............................................................................................. 100
Attachment K1 – Order of Nondistribution ............................................................... 110
Attachment K2 – Hearing Report Cover Letter ........................................................ 111
Attachment K3 – Hearing Report ............................................................................. 112
Attachment K4 – Vacated Order of Nondistribution ................................................. 113
Attachment K5 – Continued order of Nondistribution ............................................... 114
Attachment K6 – Amended Order to Include Recall ................................................ 115
Attachment K7 – Notification, Nondistribution, and Recall of Controlled Substances
for Human or Animal Use Process Flow Chart ........................................................ 116
Attachment L – Models for Standardized Recall Audit Check (RAC) Levels and
Effectiveness of the Recall Notification System for Human Food Recalls ............... 117
Attachment M – Medical Device Safety Alerts ......................................................... 122
Exhibit 7-1 Model Effectiveness Check Letter (Industry) ......................................... 123
Exhibit 7-2 Model Effectiveness Check Response Format (Industry) ...................... 124
Exhibit 7-3 Model Effectiveness Check Questionnaire for Telephone or Personal
Visits (Industry) ........................................................................................................ 126
Exhibit 7-4 Model Recall Letter (Generic, All Centers)............................................. 128
Exhibit 7-5 Model Recall Return Response Form .................................................... 130
Exhibit 7-6 Model Recall Envelope .......................................................................... 132
Exhibit 7-7 Model FDA Requested Recall Letter ..................................................... 133
Exhibit 7-8 Model Acknowledgement (to be used when RES automated email request
cannot be used due to the RES not functioning or the firm not having an email
address)................................................................................................................... 135
Exhibit 7-9 Model Notification of Classification Letter (FDA to Recalling Firm) ........ 138
Exhibit 7-10 Model Recall Ineffective Recall Letter .................................................. 139
Exhibit 7-11 Model Recall Termination Letter .......................................................... 140
Exhibit 7-12 Model Combined Recall Notification of Classification and Termination
Letter .................................................................................................................... 141
Exhibit 7-13 Model Recall Audit Check Memo Assignment ..................................... 142
Exhibit 7-14 Initiating RAC by Mail or Email ............................................................ 143
Exhibit 7-15 Weekly Class I Recall Status Report (Optional)................................... 144
Exhibit 7-16 Recall Status Report Request Letter (to be used when RES automated
email request cannot be used due to the RES not functioning or the firm not having
an email address) .................................................................................................... 145
Exhibit 7-17 Model Reconditioning Proposal Template (FDA to Recalling Firm) ..... 147
Exhibit 7-18 Market Withdrawal Designation Template ........................................... 150
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Exhibit 7-19 Market Withdrawal Designation – Additional Information Requested .. 151
Exhibit 7-20 Market Withdrawl Close Out to be Used when additional information was
requested................................................................................................................. 152
Appendix A FDA Food Recall/Action Initiation Process Flow/Timeline for Class I
Human Food Recalls (SAHCODH) .......................................................................... 153
7-1 PURPOSE
This chapter provides definitions, responsibilities, and procedures for agency
components to initiate, review, classify, publish, audit and terminate recall actions. It
implements 21 CFR Part 7 Subpart C – Recalls (Including Product Corrections) –
Guidelines on Policy, Procedures, and Industry Responsibilities. See also Investigations
Operations Manual (IOM) Chapter 7 - Recall Activities. It also discusses FDA non-
voluntary recalls and includes a reference to the procedures for implementing each of
these authorities, including recalls of Medical Devices, Radiation Emitting Electronic
Products, Biological Products, Human Tissue Intended for Transplantation, Infant
Formula, Tobacco Products, and Food Products

7-2 BACKGROUND
Recalls are an effective method for removing or correcting marketed products, their
labeling, and/or promotional literature that violate the laws administered by the Food
and Drug Administration (FDA). Recalls afford equal consumer protection but generally
are more efficient and timely than formal administrative or judicial actions, especially
when the product has been widely distributed

FDA regulated firms may initiate a recall at any time to fulfill their responsibility to
protect the public health from products that present a risk of injury or gross deception or
are otherwise defective. Firms may also initiate a recall following notification of a
problem by FDA or a state agency, in response to a formal request by FDA, as
statutorily mandated or as ordered by FDA

All agency components are expected to follow the requirements of this chapter

Although this chapter primarily implements 21 CFR Part 7 Subpart C, some deviation
from the policy, definitions, responsibilities, and procedures under 21 CFR Part 7
Subpart C may occur with statutorily mandated and ordered recalls. See Section 7-5-3

These deviations are noted throughout this chapter

Guidelines delineating the responsibilities of industry in conducting recalls are in 21
CFR 7.40-7.59. Industry Guidance is available on the Internet at the FDA web site. It is
designed for all FDA regulated industry and provides guidance both in the conduct of
recalls and in the information needed by FDA to classify, monitor, and assess the
effectiveness of a recall

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7-3 SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES
FDA responsibilities are summarized below. This chapter is arranged according to the
following outline:
1. Initiation of a Recall. Includes voluntary, and non-voluntary recalls

2. Determination that the Action is a Recall; Strategy; Classification. FDA formalizes
the recall action by determining that the action meets the definition of a recall
under 21 CFR 7.3(g) 1 or the applicable definitions for recalls conducted under
different regulatory or statutory authorities. FDA reviews the information,
including the recall strategy provided by the firm, assesses the health hazard
presented by the recalled product, and classifies the recall in accordance with 21
CFR 7.41

3. Notification and Public Announcement. FDA reviews a firm’s recall strategy and
suggests changes, including the issuance of a public announcement. FDA
notifies the firm of the classification of the recall. The agency may issue its own
public announcement of a firm’s recall. FDA posts information about recalls at
various locations on the FDA’s Internet site: www.fda.gov/. FDA provides recall
information to other federal and state government agencies and to foreign
governments

4. Monitoring and Auditing the Recall. FDA develops and implements a recall audit
strategy to ensure that the recall action has been effective

5. Termination of a Recall. FDA determines when a recall should be terminated

FDA may take appropriate regulatory action or other measures when the firm fails to
recall violative product or when a recall action fails. Regulatory actions will be taken in
consultation and coordination with the appropriate compliance branch, the appropriate
center recall and compliance staffs, OSPOP/DE/ROB, and when indicated, the Office of
Chief Counsel, when:
a firm refuses to recall or sub-recall after being requested or ordered to do so by
the FDA;
or
the agency has reason to believe that the firm’s recall strategy is not effective,
or is not being implemented effectively
1 As defined in 21 CFR 7.3(g), “Recall means a firm’s removal or correction of a marketed product that the
Food and Drug Administration considers to be in violation of the laws it administers and against which the
agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or stock
recovery.” As defined in 21 CFR 7.3(j), “Market withdrawal means a firm’s removal or correction of a
distributed product which involves a minor violation that would not be subject to legal action by the Food
and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.”
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7-3-1 Responsibilities of the Office of Strategic Planning and Operational
Policy/Division of Enforcement/Recall Operations Branch (OSPOP/DE/ROB)
OSPOP/DE/ROB responsibilities are detailed in SMG 1121.81. OSPOP/DE/ROB
serves as the agency focal point for guidance on recall plans and recall procedures;
directs and coordinates field activities in support of all product recalls; and maintains
communication with other agency components, industry, and domestic and foreign
government agencies to ensure proper implementation and completion of recall plans
and activities

7-3-2 Responsibilities and Procedures – ORA/Office of Partnerships and
Operational Policy (OPOP)
The responsibilities of Office of Strategic Planning and Operational Policy (OSPOP), in
Office of Partnerships and Operational Policy (OPOP), are detailed in SMG 1121.70

OSPOP develops, coordinates, and reviews compliance policies and regulatory
procedures that can relate to recalls

7-3-3 Responsibilities and Procedures – Office of Information Systems
Management/ Division of System Solutions (DSS) /Enforcement Systems
Branch
OISM/DSS/ESB responsibilities are detailed in SMG 1121.812. DSS/ESB supplies
recall information to internal FDA entities, in response to Freedom of Information Act
(FOIA) requests, and, as appropriate, to applicable government agencies under the
Government-Wide Quality Assurance Program (GWQAP). DSS/ESB is the business
owner for the Enforcement Report application

7-4 RECALL ENTERPRISE SYSTEM
The Recall Enterprise System (RES) is an electronic data system used by FDA recall
personnel to submit, update, classify, and terminate recalls. It is also used to capture
medical device Safety Alerts, see Attachment M. Market withdrawals andstock
recoveries, are not normally entered into RES. However, divisions may, consistent with
agency policy, be directed by the Center Recall Unit (CRU) or OSPOP/DE/ROB to
enter a specific market withdrawal into RES and to monitor and audit the action in the
same manner as a recall

There may also be some instances where a division enters an action into RES and the
CRU determines that the action does not meet the definition of a recall. The CRU will
designate the action in RES as a market withdrawal or stock recovery. The CRU may
also non-concur with the recall recommendation, for example in instances where a
product is not under FDA jurisdiction and the recall is referred to another agency

RES User Guides contain the detailed information needed for the use of RES

Electronic copies of the guides have been provided to field and center recall
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coordinators. The RES application currently has help information available for each
screen. The RES increases efficiency in processing recall information by:
1. allowing field and center recall coordinators to input recall information via an
on-line, Intranet system that captures all stages of the recall;
2. increasing communication of recall information between the field,
headquarters, and the appropriate center(s) offices and reducing duplication of
efforts;
3. providing a central, searchable database to more efficiently track information
and generate and disseminate reports of recall activities

The information entered in RES is gathered from various sources, including, the firm,
ORA and the CRU. ORA is the business owner for the RES database. A RES account
can be obtained by providing a FACTS User ID and completing the RES Account
Request Form available on Inside FDA. Submit the form via the preferred method of
electronic mail to ORA Recall OE and indicate “RES Account Request” on the subject
line. A Recall Operations Branch member will contact the requestor for the type of
account or access that is requested and needed. Issues with RES (e.g. data entry,
inability to access a record, failure of auto-generated emails delivered or sent) should
be directed to the ORA Apps Desk

Requests for deletion of RES events (such as duplicate events) should be directed to
the OSPOP/DE recall staff, except for CBER events contact the CBER CRU

7-4-1 Enforcement Report
The Enforcement Report is an online weekly publication of all recalls monitored by FDA
once they are classified (21 CFR 7.50) and may be listed prior to classification when
FDA determines the firm’s removal or correction of a marketed product(s) meets the
definition of a recall. Those records published prior to classification are referred to as
"not yet classified" records. Recalls and "not yet classified" records are directly sourced
from RES and are compiled into weekly reports based on the classification date or the
date the record is determined to meet the definition of a recall. Recalls and "not yet
classified" records are posted to the Enforcement Report when Centers set the recall
to be posted in RES. More information can be found on the Enforcement Report home
page

Note: Change requests to the Enforcement Report should be directed to the CRU

7-5 INITIATION OF A RECALL
A manufacturer or distributor may voluntarily initiate a recall at any time. Initiation of a
recall means a recalling firm's first communication about a voluntary recall, to its direct
accounts or to the public. FDA may conduct informal discussions with a manufacturer
or distributor that include voluntary recall as an option. FDA may also request a recall,
as provided for under 21 CFR 7.45. Under certain authorities, FDA may mandate a
recall

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If the firm that has primary responsibility for the manufacture or distributing or marketing
of the product to be recalled is out of business or is unable to conduct an effective recall
for any reason, the division should notify the CRU and OSPOP/DE/ROB. The division
and the CRU should develop an appropriate course of action. In significant situations
involving a serious health hazard, this could involve issuance of press to notify the
public and/or FDA notifying consignees directly

Note: FDA Food Recall/Action Initiation Process Flow – Timeline for Class I Human
Food Recalls (SAHCODH) is in Appendix A. It describes a timeline for FDA to follow in
pursuing Class I food recalls and provides options to follow should a firm not initiate a
recall

7-5-1 Firm Initiated Recalls
If a recall is firm-initiated under 21 CFR 7.46, the agency will review the information
provided by the recalling firm under 21 CFR 7.46(a). This includes reviewing and
suggesting changes to the firm’s recall strategy, recall communication, and press
release (if necessary)

FDA may inform a firm that a product violates the law and recommend they cease
distribution and recall the product without specifically requesting a recall

Evidence to support FDA’s recommendation may be collected by FDA, a federal or
state partner, or a third party

If a firm decides to recall under these circumstances, the firm’s action is considered a
firm-initiated recall under 21 CFR 7.46(c). If a firm asks whether FDA is requesting a
recall, FDA should explain that it is not requesting a recall, as a determination under 21
CFR 7.45 has not been made and that the agency has not exercised its authority under
21 CFR 7.45, or invoked its mandatory recall authority. This recommendation does not
preclude FDA from considering other actions in the future

When considering FDA’s authority to request that a firm initiate a recall, see 21 CFR
7.45 and RPM Section 7-5-2, FDA Requested Recall

When considering cease distribution and voluntary recalls under section 423(a) of the
Act, see RPM Section 7-5-3, FDA Mandated Recalls

Discussions with firms about firm-initiated recalls pursuant to a recommendation shall
be conducted by: (1) the Program Director or designee, with the concurrence of the
Center Director of the Office of Compliance or designee; or (2) the Center Director of
the Office of Compliance or designee, with the concurrence of the Program Director or
designee

• These discussions may occur during conversations with the firm(s), the firm’s US
agent (for a foreign firm), or the firm’s legal representative. Such discussions
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should be documented in internal meeting minutes or notes, in accordance with
agency’s procedures

If the firm does not agree to cease distribution and/or recall following FDA’s
recommendation, the agency may consider further action, as appropriate, including, but
not limited to: public notification to consumers, healthcare practitioners, etc., an FDA-
requested recall letter, an FDA-mandated recall (in the case of certain regulated
products), seizure, administrative detention, or injunction. ORA and the Center(s) will
consider taking appropriate follow-up action. ORA and the Center(s) will also determine
whether the potential recall could cause a shortage of a regulated product and identify
appropriate timeframes in which to accomplish these tasks based on the degree of risk
associated with the recall

The agency will conduct a health hazard evaluation (HHE), (precedent HHEs or written
classification policies may be used), will classify the recall, and will advise the firm in
writing of the assigned recall classification. The letter to the firm will recommend any
appropriate changes in the firm's recall strategy and advise the firm that its recall will be
placed on the FDA web site. FDA will also assign audit checks as appropriate, will
monitor the effectiveness of the recall communication, correction or removal, will verify
appropriate product disposition, and will terminate the recall when appropriate

The division:
• submits a Recall Alert;
• gathers information about the recall. It may conduct an establishment inspection
and collect samples of the recalled or other suspect products;
• submits a Recall Recommendation and other information about the recalled
product to the appropriate center;
• offers guidance to the recalling firm;
• monitors the recall; and,
• terminates Class II and III recalls and recommends termination for Class I recalls

When program divisions need assistance (recall associated with an emergency, high
volume of recalls, etc.) the division should seek assistance from other divisions within
their program and follow local and/or program procedures. If the entire program is
experiencing a resource issue, seek assistance outside of the program after consulting
with Program Directors

1. Recall Alert
The division will submit a recall alert through RES within one working day after the
division recall coordinator has learned that a recall has been initiated and the
division recall coordinator has obtained the necessary information as described in
Attachment A. Alerts may also be submitted before a recall has been initiated. The
purpose of the recall alert is to notify the appropriate CRU and OSPOP/DE/ROB of a
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firm’s correction or removal, the reason for recall, and anticipated classification. For
recalls where the manufacturing site or responsible firm is located outside the
monitoring division, copy the division recall staff where the manufacturing site or
responsible firm is located

2. Recall Recommendation and Related Information
The purpose of a recall recommendation is to notify the CRU and OSPOP/DE/ROB
Recall that the firm’s action is recommended as a recall and its anticipated
classification. Additionally, it serves as a notification to the CRU that the necessary
information is available and entered in RES for the CRU to review and classify the
recall. The division must submit a complete Recall Recommendation (RR) through
RES within five working days after the recalling firm has provided the information
necessary for the RR. When the information is submitted through the RES system, it
automatically alerts the appropriate CRU and OSPOP/DE/ROB via e-mail. See
Attachment B for guidance on the information required by the CRU to review and
classify the recall. When sending recommendations where the manufacturing site or
responsible firm is located outside the monitoring division, copy the division recall
staff where the manufacturing site or responsible firm is located

If the recall has been completed before FDA's knowledge of it, division personnel
should obtain documentation of actions taken to dispose of or recondition the
recalled products and document the recall per normal procedure. This
documentation may include processing records or laboratory analysis, process
validation protocols and reports, signed destruction receipts, salesperson's written
receipts, corporate official's signed statement on firm's stationery, etc. The division
should update RES with the recommendation information within 10 working days of
learning of the completed recall

In the case of potential class I recalls (or some urgent Class II recalls that, while not
rising to Class I hazards, still present a serious hazard to health), if a firm has not
provided adequate information to submit a recall recommendation after a reasonable
request has been made, the division should consider assigning or conducting a
directed inspection to obtain the information. If information is needed from a firm in
another division, the monitoring division should request an inspection from that
division

If there is insufficient information to submit an RR, the division recall coordinator
should telephone or email the appropriate CRU and OSPOP/DE/ROB for advice on
a course of action

Notes:
1. When requested by OSPOP/DE/ROB or the CRU, submit an RR for a
product removal as a result of actual or alleged tampering with individual
unit(s) where there is no evidence of manufacturer or distributor
responsibility. They should recommend the action be designated as a
market withdrawal since, although the situation may present a health
hazard, there is no one identified as responsible for the violation. This RR
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submission and market withdrawal recommendation will allow
documentation and monitoring of the market withdrawal. For additional
tampering related information see RPM Chapter 8 – Emergency
Procedures and IOM Chapter 8 – Investigations
2. FDA does not ordinarily classify or audit interstate milk shippers (IMS) and
Interstate Shellfish Shippers (ISS) product recalls where such actions
have been, or are being, handled expeditiously and appropriately by the
state(s). The FDA division office in which the recalling firm is located must
be ensured that all state(s) involved in an IMS plant's recall are
participating in ensuring removal of the product from commerce and that,
when appropriate, state(s) issue warnings to protect the public health. In
the event that FDA determines that the states are unable to effect the
recall actions necessary, the agency will classify, publish, and audit the
recall, including issuance of a public warning when indicated

3. Exported products may not be documented in RES when the following
scenarios apply:
• The product(s) are labeled for export only, and/or
• The product(s) are labeled for foreign distribution only (e.g. all
labeling in foreign language), and/or
• The recall is already monitored by competent foreign authority (e.g

the U.S. firm contract manufactured for a foreign firm, no U.S

distribution, and the foreign firm assumes responsibility for recalling
marketed product and has reported the recall to be monitored by
the foreign authority, and/or
• Foreign firm is the recalling firm and has no U.S. distribution

3. Establishment Inspection
For domestic firms, the division will contact the firm to obtain recall information and,
in the case of recalls that have been classified as or appear to be class I or
significant class II recalls, the situation should be evaluated to determine if an
establishment inspection should be assigned to determine the root cause of the
problem and document violations for possible regulatory action. See the IOM
Chapter 7 – Recall Activities for information on how to conduct recall related
inspections

In many recall situations, the firm’s production facility may differ from the recalling
facility, typically a headquarters or corporate office. The recall also may have been
initiated due to a problem at a supplier or another separate establishment. If the
monitoring division determines an inspection is needed at an establishment located
in another division, the monitoring division will contact that division and request an
inspection. The investigating division, in turn, should keep the monitoring division
informed of the inspectional progress and findings. If an inspection is needed at a
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foreign facility, ORA Headquarters or a Center may request an inspection at that
facility. Requests for these inspections vary for each program area, depending on a
variety of factors (e.g. the firm’s inspectional history)

4. Official Samples
The division must determine the need for an official sample, either physical or
documentary. Typically collect samples when they best demonstrate the defect and
potential hazard. The decision to collect an official sample is a division management
prerogative unless required by specific headquarters' initiated assignments, or the
occasional direct request from the CRU or OSPOP/DE/ROB. Samples collected
should document interstate movement as well as the violation

5. Firm Recall Communication and Notification
The FDA Division Recall Coordinator (DRC) should offer guidance to the recalling
firm and will offer to review the text of recall communications to consignees so that
the product will be promptly removed or corrected. The CRU and OSPOP/DE/ROB
staff are available, if necessary, to assist the DRC. Recall communications can be in
multiple forms including press releases, telephone calls, telegrams, telefaxes,
mailgrams, or first class letters. For tobacco products, the Center for Tobacco
Products should be contacted for guidance on any recall communications and
notifications submitted by the recalling firm

The recalling firm should discuss any recall communications and notifications with
the FDA DRC before issuance. The possible need for bilingual or multilingual
communications should be explored between the FDA DRC and the firm

All recall communications should be written in accordance with the following
guidelines: be brief and to the point; clearly identify the product(s) such as the
product name, size, brand name, serial numbers(s), potency, dosage, type, model,
lot number(s), UPC codes, Unique Device Identifier (UDI) if applicable, and any
other pertinent descriptive information to enable accurate and immediate
identification of the product; contain a concise statement of the reason for the recall;
state known or potential hazard(s), and instructions for consignees to follow in
handling the recall. If possible, the recall letter may provide the initial shipping date
and quantities shipped. See Exhibit 7-4 Model Recall Letter

If a firm has voluntarily initiated a recall of any product(s), then it is responsible for
promptly notifying each of its direct accounts. If the depth of the recall is beyond the
direct accounts, then the direct accounts should be instructed by the recalling firm to
contact sub-accounts that may have received the product

Sub-accounts, which further distributed the product, should continue the recall to the
depth established in the recall strategy. A written recall communication to
sub-accounts should be in addition to any other means of communication, such as
monthly sales bulletins, manufacturer representative visits, or recorded phone
messages. These actions may aid in a sub-recall effort, but they are an inadequate
communication of the recall

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Regulatory Procedures Manual July 2021 Chapter 7 Recall Procedures MAN-000010 . Page 4 of 153 VERSION 10 . Exhibit 7-19 Market Withdrawal Designation – Additional Information Requested .. 151

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Frequently Asked Questions

What is the regulatory procedures manual?

The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.

What is the regulatory procedures manual for import and export entries?

Regulatory Procedures Manual January 2022 Chapter 9 Import Operations and Actions MAN-000012 Page 88 of 113 VERSION 03 such importations and import for export entries will be included in the FDA’s filer evaluation conducted by the responsible FDA office. For manual entry submissions, or when FDA has requested supporting paper entry

What are the general procedures of fda for importing products?

GENERAL PROCEDURES The Federal Food, Drug and Cosmetic Act (the Act), Section 801, directs FDA to refuse admission of any article that appears to be in violation of the Act. To ensure that FDA is notified of all regulated products imported into the United States,

What is the purpose of the fda office of internal procedures?

It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.