Arnold Best Recall Coordinator U. S. Food & Drug Administration

Arnold BestArnold BestRecall CoordinatorRecall Coordinator

U. S. Food & Drug AdministrationU. S. Food & Drug Administration

Definition:Definition: RECALLRECALL Firm’s removal of marketed product that Firm’s removal of marketed product that

the Food & Drug Administration considers the Food & Drug Administration considers to be in violation of the law it administers to be in violation of the law it administers and against which the agency would and against which the agency would initiate legal action; e.g., seizure.initiate legal action; e.g., seizure.

Does not include a Does not include a market withdrawalmarket withdrawal or a or a stock recoverystock recovery..

21 CFR Part 7.3(g)21 CFR Part 7.3(g)

Definition:Definition: MARKET MARKET WITHDRAWALWITHDRAWAL

Firm’s removal or correction of a Firm’s removal or correction of a distributed product which involves a minor distributed product which involves a minor violation that would not be subject to legal violation that would not be subject to legal action by FDA or which involves no action by FDA or which involves no violation, e.g., normal stock rotation violation, e.g., normal stock rotation practices, routine equipment adjustments practices, routine equipment adjustments and repairs, etc.and repairs, etc.

21 CFR Part 7.3(j)21 CFR Part 7.3(j)

Definition:Definition: STOCK RECOVERYSTOCK RECOVERY

Firm’s removal or correction of a product Firm’s removal or correction of a product that has not been marketed or that has not that has not been marketed or that has not left the direct control of the firm, e.g., the left the direct control of the firm, e.g., the product is located on premises owned by, product is located on premises owned by, or under the control of, the firm and no or under the control of, the firm and no portion of the lot has been released for sale portion of the lot has been released for sale or use.or use.

21 CFR Part 7.3(k)21 CFR Part 7.3(k)

Definition:Definition: CORRECTIONCORRECTION

Repair, modification, adjustment, re-Repair, modification, adjustment, re-labeling, destruction, or inspection of a labeling, destruction, or inspection of a product and/or the promotional literature product and/or the promotional literature which causes the product to be violative, which causes the product to be violative, without its physical removal to some other without its physical removal to some other location.location.

21 CFR Part 7.3(h)21 CFR Part 7.3(h)

RECALLSRECALLS May be undertaken voluntarily and at any May be undertaken voluntarily and at any

time.time.

In response to a formal request by FDA.In response to a formal request by FDA.

Means of protecting the public health and Means of protecting the public health and

well-being.well-being.

Retrieving products that present a risk of Retrieving products that present a risk of

injury or gross deception or are otherwise injury or gross deception or are otherwise

defective.defective.

21 CFR Part 7.4021 CFR Part 7.40

RECALLSRECALLS

When a firm decides to initiate a product When a firm decides to initiate a product removal or correction, it should proceed removal or correction, it should proceed with the action and not wait for FDA to with the action and not wait for FDA to determine whether that action is a recall, determine whether that action is a recall, conduct a hazard evaluation, classify the conduct a hazard evaluation, classify the recall, and review the strategy for that recall, and review the strategy for that recall.recall.

RECALLRECALL

The recall of an FDA-regulated product is The recall of an FDA-regulated product is the responsibility of both FDA and the the responsibility of both FDA and the firm responsible for the manufacture of firm responsible for the manufacture of that product. This is essential to define that product. This is essential to define not only FDA’s role in product recalls, but not only FDA’s role in product recalls, but industry’s as well because ultimately the industry’s as well because ultimately the recall procedures that a firm follows recall procedures that a firm follows actually determines the success or failure actually determines the success or failure of a particular recall.of a particular recall.

RECALLRECALL

A voluntary recall does not preclude FDA A voluntary recall does not preclude FDA from invoking any of its regulatory from invoking any of its regulatory powers.powers.

Because a recall similar to seizure in basis Because a recall similar to seizure in basis and effect, injunction, criminal and effect, injunction, criminal prosecution, and/or other sanctions may prosecution, and/or other sanctions may be also appropriate in a recall situations.be also appropriate in a recall situations.

RECALLRECALL

A firm can first make an initial decision A firm can first make an initial decision whether an action is a recall; however, whether an action is a recall; however, FDA makes the final decision as to FDA makes the final decision as to whether the firm’s removal or correction whether the firm’s removal or correction constitutes an FDA recall.constitutes an FDA recall.

FDA has the responsibility for deciding FDA has the responsibility for deciding when a firm’s action is or is not a recall.when a firm’s action is or is not a recall.

TYPES OF RECALLSTYPES OF RECALLS

FIRM INITIATED (most common):FIRM INITIATED (most common): Initiated by a firm independently and Initiated by a firm independently and

under any circumstances to remove or under any circumstances to remove or correct a distributed product.correct a distributed product.

Initiated by a firm when informed by the Initiated by a firm when informed by the FDA that the product in question violates FDA that the product in question violates the law, but the agency has not the law, but the agency has not specifically requested a recall.specifically requested a recall.


TYPES OF RECALLSTYPES OF RECALLSFDA REQUESTED - The Commissioner of FDA or FDA REQUESTED - The Commissioner of FDA or his designee may request a firm to initiate a recall his designee may request a firm to initiate a recall when the following determinations have been when the following determinations have been made:made: Urgent situation;Urgent situation; Risk of illness, injury, or gross consumer Risk of illness, injury, or gross consumer

deception;deception; Firm has not initiated a recall; and/orFirm has not initiated a recall; and/or Necessary to protect public health and welfare.Necessary to protect public health and welfare.


Definition:Definition: RECALLING RECALLING FIRMFIRM

The firm who initiates a recall, or in the The firm who initiates a recall, or in the case of an FDA-requested recall, the firm case of an FDA-requested recall, the firm that has primary responsibility for the that has primary responsibility for the manufacturing and marketing of the manufacturing and marketing of the product to be recalled.product to be recalled.

21 CFR Part 7.3(i)21 CFR Part 7.3(i)

Definition:Definition: RECALL STRATEGYRECALL STRATEGY

A planned specific course of action to be A planned specific course of action to be taken in conducting a specific recall, which taken in conducting a specific recall, which addresses the depth of recall, need for addresses the depth of recall, need for public warning, and extent of effectiveness public warning, and extent of effectiveness checks for the recall.checks for the recall.

21 CFR Part 7.3(1)21 CFR Part 7.3(1)

RECALL STRATEGYRECALL STRATEGY

The planned course of action to be carried out The planned course of action to be carried out by the firm in the achievement of its recall by the firm in the achievement of its recall goals.goals.

The FDA will review and/or recommend changes The FDA will review and/or recommend changes to the firm’s recall strategy, as appropriate.to the firm’s recall strategy, as appropriate.


RECALL STRATEGY RECALL STRATEGY FACTORSFACTORS

Results of firm’s health hazard evaluation.Results of firm’s health hazard evaluation.

Ease in identifying the product.Ease in identifying the product.

Degree to which the product’s deficiency Degree to which the product’s deficiency is obvious to the consumer or user.is obvious to the consumer or user.

Degree to which the product remains Degree to which the product remains unused in the marketplace.unused in the marketplace.

Continued availability of essential Continued availability of essential products.products.

HEALTH HAZARD HEALTH HAZARD EVALUATIONEVALUATION

Evaluation by FDA scientists of the threat to Evaluation by FDA scientists of the threat to health presented by a product, including its health presented by a product, including its labeling and/or promotional literature, that labeling and/or promotional literature, that is being recalled or considered for recall.is being recalled or considered for recall.


HEALTH HAZARD HEALTH HAZARD FACTORSFACTORS

Any disease or injury has occurred.Any disease or injury has occurred. Any contributing factors.Any contributing factors. Assessment of hazard to various segments Assessment of hazard to various segments

of the population.of the population. Assessment of the degree of seriousness.Assessment of the degree of seriousness. Assessment of the likelihood of occurrence.Assessment of the likelihood of occurrence. Assessment of the consequences of Assessment of the consequences of

occurrence.occurrence.

DEPTH OF RECALLDEPTH OF RECALL

Level in the distribution chain to which Level in the distribution chain to which the recall is to be extended.the recall is to be extended.

Depends on the product’s degree of Depends on the product’s degree of hazard and the extent of distribution.hazard and the extent of distribution.

Consumer or user level.Consumer or user level. Retail level.Retail level. Wholesale level.Wholesale level.

21 CFR Part 7.42(b)(1)21 CFR Part 7.42(b)(1)

Definition:Definition: CONSIGNEECONSIGNEE

Anyone who received, purchased, or used Anyone who received, purchased, or used the product being recalled.the product being recalled.

21 CFR Part 7.3(n)21 CFR Part 7.3(n)

RECALL RECALL COMMUNICATIONSCOMMUNICATIONS

Should be brief and to the point.Should be brief and to the point. Clearly identify the product.Clearly identify the product. Concisely explain the reason for the recall Concisely explain the reason for the recall

and the hazard involved.and the hazard involved. Provide specific instruction on what Provide specific instruction on what

should be done with respect to the should be done with respect to the recalled product(s).recalled product(s).


Convey the name of the recalled product.Convey the name of the recalled product. Further distribution or use of any Further distribution or use of any

remaining product should cease remaining product should cease immediately.immediately.

When appropriate, that the direct account When appropriate, that the direct account should conduct a sub-recall.should conduct a sub-recall.

Instructions regarding what to do with the Instructions regarding what to do with the product.product.

21 CFR Part 7.49(a)21 CFR Part 7.49(a)


Should not be diluted or camouflaged by Should not be diluted or camouflaged by irrelevant qualifications, promotional irrelevant qualifications, promotional materials, or any other statement or materials, or any other statement or information that may detract from the information that may detract from the message.message.

21 CFR Part 7.49(c)(2)21 CFR Part 7.49(c)(2)


Provide a means for the recipientProvide a means for the recipient

to report back to the recalling to report back to the recalling firm.firm.

21 CFR Part 7.49(c)(1)21 CFR Part 7.49(c)(1)

RES: Recall EnterpriseRES: Recall Enterprise SystemSystem

Automated systemAutomated system Track Recalls NationwideTrack Recalls Nationwide Consistency in recall reportingConsistency in recall reporting Time efficientTime efficient Real time agency awarenessReal time agency awareness Real time public awareness (Internet)Real time public awareness (Internet)

RECALL CLASSIFICATIONSRECALL CLASSIFICATIONS

CLASS ICLASS I: A situation in which there is a : A situation in which there is a reasonable probability that the use of, or reasonable probability that the use of, or exposure to, a violative product will cause exposure to, a violative product will cause serious adverse health consequences or serious adverse health consequences or death.death.

21 CFR Part 7.3(m)(1)21 CFR Part 7.3(m)(1)

PUBLIC WARNINGSPUBLIC WARNINGS Purpose is to alert the public health that the Purpose is to alert the public health that the

recalled product presents a serious hazard recalled product presents a serious hazard to health.to health.

Reserved for urgent situations where other Reserved for urgent situations where other means for preventing use appear means for preventing use appear inadequate.inadequate.

Issued through the general news media, Issued through the general news media, and/or the specialized news media, or to and/or the specialized news media, or to specific segments of the population.specific segments of the population.

21 CFR 7.42(b)(2)21 CFR 7.42(b)(2)


CLASS II: CLASS II: A situation in which use of, or A situation in which use of, or exposure to, a violative product may cause exposure to, a violative product may cause temporary or medically reversible adverse temporary or medically reversible adverse consequences or where the probability of consequences or where the probability of serious adverse health consequences is serious adverse health consequences is remote.remote.



CLASS III: CLASS III: A situation in which use of, or A situation in which use of, or exposure to, a violative product is exposure to, a violative product is notnot likely to cause adverse health likely to cause adverse health consequences.consequences.


PUBLIC NOTIFICATION OF PUBLIC NOTIFICATION OF RECALLRECALL

Weekly FDA Enforcement Report:Weekly FDA Enforcement Report:

Contains a descriptive listing of each new Contains a descriptive listing of each new recall, its classification, and the specific recall, its classification, and the specific action being taken by the recalling firm.action being taken by the recalling firm.

Does not contain a firm’s product removals Does not contain a firm’s product removals or corrections, which are classified as or corrections, which are classified as market withdrawals or stock recoveries.market withdrawals or stock recoveries.


EFFECTIVENESS EFFECTIVENESS CHECKSCHECKS

Conducted by the recalling firm.Conducted by the recalling firm. Verify that all consignees have received Verify that all consignees have received

notification about the recall and have notification about the recall and have taken appropriate action.taken appropriate action.

If not done, the firm is not meeting its If not done, the firm is not meeting its obligation and responsibility to the obligation and responsibility to the consumer.consumer.

21 CFR Part 7.42 (b)(3)21 CFR Part 7.42 (b)(3)

RECALL STATUS RECALL STATUS REPORTSREPORTS

Recalling firm is requested to submit Recalling firm is requested to submit periodic recall status reports so that an periodic recall status reports so that an assessment can be made of the progress of assessment can be made of the progress of the recall.the recall.

Frequently will be determined by the Frequently will be determined by the relative urgency of the recall.relative urgency of the recall.


RECALL STATUS RECALL STATUS REPORTSREPORTS

Should contain the following information: Should contain the following information:

Number of consignees notified, date, and Number of consignees notified, date, and method.method.

Number of responders and quantity on hand.Number of responders and quantity on hand.

Number of non-responders.Number of non-responders.

Amount product returned or corrected and Amount product returned or corrected and quantity accounted for.quantity accounted for.

Number and results of effectiveness checks.Number and results of effectiveness checks.

Estimated time frames for completion.Estimated time frames for completion.

LEVEL OF AUDIT LEVEL OF AUDIT CHECKSCHECKS

Percentage of total number of consignees Percentage of total number of consignees contacted:contacted:

Level A – 100%Level A – 100% Level B – greater than 10% but less Level B – greater than 10% but less

then 100%then 100% Level C – 10%Level C – 10% Level D – 2%Level D – 2% Level E – No effectiveness checks.Level E – No effectiveness checks.

FDA RECALL AUDIT CHECK FDA RECALL AUDIT CHECK PROGRAMPROGRAM

Audit checks determine the adequacy of Audit checks determine the adequacy of the firm’s effectiveness checks.the firm’s effectiveness checks.

Audit checks are decided upon after Audit checks are decided upon after evaluating the recalling firm’s strategy.evaluating the recalling firm’s strategy.

Audit checks are conducted by:Audit checks are conducted by:

- Personal visits- Personal visits

- Telephone calls- Telephone calls

TERMINATION OF RECALLTERMINATION OF RECALL

Occurs when FDA has determined that Occurs when FDA has determined that all reasonable efforts have been made to all reasonable efforts have been made to remove or correct the violative product remove or correct the violative product in accordance with the recall strategy in accordance with the recall strategy and proper disposition has been made and proper disposition has been made according to the degree of hazard.according to the degree of hazard.

21 CFR 7.5521 CFR 7.55

FDA/Atlanta District FDA/Atlanta District ContactsContacts

Arnold E. Best, Recall Coordinator (404) Arnold E. Best, Recall Coordinator (404) 253-1293253-1293

Sheryl R. Cruse, CO (Recall Back-up) Sheryl R. Cruse, CO (Recall Back-up) (404) 253-1278(404) 253-1278

Barbara Wood, DCB (404) 253-1274Barbara Wood, DCB (404) 253-1274 Mary Woleske, DD (404) 253-5226Mary Woleske, DD (404) 253-5226

WEBSITESWEBSITESFDA Weekly Enforcement ReportFDA Weekly Enforcement Report

www.fda.govwww.fda.gov Go to What’s New and click on search,Go to What’s New and click on search, Highlight the Weekly Enforcement Report,Highlight the Weekly Enforcement Report, Go to the box on the left and type in what Go to the box on the left and type in what

you are searching for, then hit search.you are searching for, then hit search.

Food Safety Alert and NewsFood Safety Alert and News This is part of the This is part of the www.FoodSafety.govwww.FoodSafety.gov

websitewebsite

Arnold Best Recall Coordinator U. S. Food & Drug Administration

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