Learn how to comply with the upcoming preventive control rules related to food recalls, and more in this 60-minute audio session.

1. Food Recall Readiness - Is Your Plan In Place?
Identify Resources for Writing and Testing a Written Recall Plan
Presenter - Ben Miller
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2. What is a recall?
 Recall – a firm’s removal or correction of a marketed
product that is in violation of the law, and against which
FDA would initiate legal action.
Reference: 21 CFR 7.3(g)

3. What triggers a food recall?
 Potentially hazardous to the public or animals
 Microbiological or Chemical Contamination
 Laboratory Confirmed
 Produced or held under conditions whereby product may be
adulterated
 Linked to confirmed outbreak of foodborne illness
 May be independent of laboratory results
 Is in violation of the Federal Food, Drug, and Cosmetic
Act or State Statute or Rule
 Labeling violations
 Allergens, etc

4. Types of Recalls
 Class I recall: a situation in which there is a reasonable probability that
the use of or exposure to a violative product will cause serious adverse
health consequences or death.
 Class II recall: a situation in which use of or exposure to a violative
product may cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse health
consequences is remote.
 Class III recall: a situation in which use of or exposure to a violative
product is not likely to cause adverse health consequences.
 Market withdrawal: occurs when a product has a minor violation that
would not be subject to FDA legal action. The firm removes the product
from the market or corrects the violation. For example, a product
removed from the market due to tampering, without evidence of
manufacturing or distribution problems, would be a market withdrawal.

5. What Does a Firm Do When a Problem is
Detected in a Marketed Product?
 Review, analyze, discuss, debate
 Often get to the decision point: ‘remove the product
from the market’
 Then:
 Scope
 Strategy
 Notification
 Execution
 Verification
 Analysis

6. To see the complete presentation check the
below link:
http://www.audioeducator.com/food-safety/food-recall-readiness-
09-08-14.html