Transcript FSMA Training Industry Readiness Best Practices

FSMA TRAINING
Industry Recall Readiness
BEST PRACTICES
Warm Welcome
Kathy Gombas
Senior Advisor
CFSAN Office of Food Safety
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FSMA Rule Readiness Training 2016 Sessions
3
Agenda
Kathy Gombas, CFSAN/OFS
 Introduction, Q&A and Wrap Up
Cecilia Wolyniak, ORA
 FDA Perspective – PC Rule Requirements
Amy Philpott, Watson Green LLC
Industry Recall Readiness Best Practices
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FDA's Responsibilities During a
Recall Event
Cecilia M. Wolyniak
FDA Office of Enforcement and Import
Operations
Overview
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Basic recall definitions
Requirements for a recall plan
FDA's roles and responsibilities in a recall
Location of guidance on FDA’s website
Definitions
• Voluntary Recall Definition (21 CFR 7.3): Recall
means a firm’s removal or correction of a
marketed product(s) 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.
Definitions
• Correction means repair, modification,
adjustment, relabeling, destruction, or
inspection (including patient monitoring) of a
product without its physical removal to some
other location
• Removal means physical removal from where a
product is used or sold to another location for
repair, relabeling, destruction, etc.
Definitions (Cont.)
• A subrecall refers to the action taken by a
recalling firm’s consignees to extend the recall
to subsequent levels of distribution, provided
that the consignee did not further
manufacture the recalled product.
Recalling firm
Distributor
Retailer
Definitions (Cont.)
• If the consignee further manufactured the
product (repacked or used as in ingredient),
they have created a new product and need to
consider if they need to initiate their own
recall
Initial Recalled
Product
Consignee used in
packaged salad –
New Recall!
Retailer
Definitions (Cont.)
• Recall Classification: Numerical
designation, i.e., I, II, or III, assigned
by the Food and Drug Administration
to a particular product recall to
indicate the relative degree of health
hazard presented by the product
being recalled.
Definitions
• Class I: reasonable probability of serious adverse
health consequences or death.
• Class II: temporary or medically reversible adverse
health consequences or where the probability of
serious adverse health consequences is remote.
• Class III: not likely to cause adverse health
consequences.
Background
Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls
(PC) Rules for
Human Food (HF) and Animal Food (AF)
• Final rules issued: September 17, 2015
Who is Covered by PCHF?
• Facilities that manufacture, process, pack or hold
human food
• In general, facilities required to register with FDA
under sec. 415 of the FD&C Act
– Not farms or retail food establishments
• Applies to domestic and imported food
• Some exemptions and modified requirements apply
Who is Covered by PCAF?
• In general, facilities that manufacture, process, pack
or hold animal food
– Facilities required to register with FDA under sec.
415 of the FD&C Act
– Not farms
• Applies to domestic and imported food
• There are some exemptions and modified
requirements for certain facilities.
Requirements for a Recall Plan
PCHF (117.139) and PCAF (507.38)
For food with a hazard requiring a preventive control
(a) Establish a written recall plan
(b) Include procedures that describe the steps to be taken, and
assign responsibility for taking those steps, to perform the following
actions:
(1) Directly notify the direct consignees of the food being recalled
(2) Notify the public about any hazard presented by the food
(3) Conduct effectiveness checks to verify that the recall is carried
out; and
(4) Appropriately dispose of the recalled food
Recall Coordinator Roles in FDA
District
Recall
Coordinator
Center Recall
Coordinator
Office of
Enforcement
and Import
Operations
DRC
• Initial POC / provides guidance
• Document recall / packages report
• Refers to Center Recall Coordinator (CRC)
CRC
• Review recall strategy
• Classify hazard
• Assign recall number
OEIO
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FDA-wide policy & procedure
Cross-cutting recall projects
Consultants to IT / recall data system staff
Post announcements to FDA.gov
FDA Recall Process
• Firm provides initial information to district; district
provides guidance to firm, including need for public
warning
• District sends recall alert to center and Office of
Enforcement and Import Operations (OEIO) recall staffs
• District obtains additional information and documentation
• District submits recommendation to center and OEIO
recall staffs; documentation to center staff
• Center conducts health hazard evaluation and classifies;
recall appears in the Enforcement Report
• District monitors until termination (Center must concur
with class I termination)
Guidelines for Voluntary Recalls 21 CFR Part 7, Subpart C:
Recalls (Including Product Corrections) – Guidelines on
Policy, Procedures, and Industry Responsibility
• Guidance for firms on development of recall
strategy (depth, public warning,
effectiveness checks) and on recall
communications with customers and FDA
• Describes procedures for FDA: assessing
hazard of recalled products, publicizing
recalls, termination of recalls
FDA Recall Guidance for Industry
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FDA Link to Recall Guidance for Industry
– List of district recall coordinators
– Links to recall regulations
– Templates for recall letters and response
forms
– Templates for press releases
– Additional recall guidance
Thank you!
Cecilia M. Wolyniak
301-796-8209
[email protected]
Questions & Answers
Kathy Gombas, CFSAN / Office of Food Safety
Q & A – Use the Adobe Connect pod to type your questions
Events for sharing industry best practices
& FDA perspectives: Upcoming events
Truth or Fiction:
10 Facts about Industry Third Party Audits - April
Points of Contact: Kathy Gombas or Jenny Murphy.
FSMA Rule Readiness Training
Resources
FDA Employees:
http://inside.fda.gov:9003/CFS
AN/CFSANStaffCollege/FoodS
afetyModernazationAct/ucm449
582.htm
State Employees:
https://www.foodshield.org
/blog-training-news/
Feedback
To submit a question about FSMA, visit
FSMA Website and go to Contact Us
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THANK YOU FOR ATTENDING
FSMA TRAINING
Industry Recall Readiness
BEST PRACTICES