Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 7.2 - RECALL NOTIFICATION / INSPECTION

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If FDA learns of a potentially violative product which may lead/has led Highlighted to denote updated text to a class I or significant class II recall, an inspection should be made to determine the root cause(s) of the problem(s). If the firm has failed to take appropriate corrective and preventive action, violations should be documented for possible regulatory action.

NOTE: In all discussions of violative or potentially violative products with the responsible firm, make it clear FDA is not requesting recall action. FDA requested recalls are authorized only by ORA, or by delegation of authority such as Drug Efficacy Study Implementation (DESI) recall requests.

When an investigation determines there is no evidence of manufacturing or distribution problems, but a firm has removed products from the market as a result of actual or alleged tampering with individual units, the action will be considered a Market Withdrawal. In addition, product that has been reported by a firm to be stolen and is being removed by the market by the firm will also be considered a market withdrawal.  A 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 FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments, repairs, theft, etc.

7.2.1 - INSPECTION PROCEDURES

An important part of your job is to identify the root cause for the recall and assure the firm has implemented procedures to prevent it from recurring. In some cases, management will have conducted its own analysis and reached conclusions about the problem and its cause. The initial judgments about the problem are not always correct nor discriminating enough to identify the underlying causes. You need to verify the steps taken were sufficient in depth and scope and reflect the correct conclusions about both the problem and correction.

Determine if the firm conducted a failure analysis using techniques such as fault tree analysis or failure mode analyses. Did it consider things such as the length of time the product has been manufactured and sold, complaints or returns for the same or similar problems, any reworking of product prior to release or distribution which may have been due to the same or similar problems and, process or personnel changes which occurred about the time the problem appeared?

For all recall inspections, in addition to verifying the identification of the root cause:

  1. Issue a Notice of Inspection (FDA 482);
  2. Discuss the suspected problem with management and review the firm's complaint file;
  3. Investigate all areas, control points and/or circumstances which may have a bearing on the product's deficiency;
  4. Fully develop individual responsibility for the problem;
  5. Review batch records, processing logs and/or other types of records for violative lots and associated lots;
  6. Review and obtain copies of the firm's quality control/analytical data;
  7. Determine any actions the firm has taken, is taking, or has planned to take to prevent similar occurrences. If corrective action is not underway, determine the firm's timetable for achieving correction; and
  8. Determine what action the firm has taken or plans to take, and the time frames involved, regarding questionable product(s) remaining in commerce.

7.2.1.1 - Recall Decision Follow-up

If the firm has decided to recall, do the following:

  1. Request that management obtain their FDA District's review of recall correspondence and any press releases before they are issued to prevent misunderstandings between the firm, its customers, and the FDA. This suggestion is voluntary on the part of the firm and is not required;
  2. If the firm requests guidance in preparing recall communications, provide it in accordance with your District policy. See Chapter 7 of the RPM and IOM Exhibit 7-1 for an example of recall communications;
  3. See RPM Chapter 7-10, Attachment B “Recommendation for Recall Classification” and 21 CFR 7.46a(1)-(9) for information to be obtained;
  4. Obtain an Official Sample of the recalled product. (See IOM 7.2.6 for the collection of samples for electronic products or medical devices.);
  5. Obtain a complete distribution list of all shipments of the suspect lot(s), including foreign distribution;
  6. Obtain specimens or copies of all labels and labeling associated with the recalled product;
  7. Obtain complete copies of all recall communications issued or planned including the text of phone conversations, and submit them to your District's recall coordinator. Look in the Blue Pages for a list of District Recall Coordinators;
  8. Advise the firm on how the returned products should be handled. FDA must witness or otherwise verify the reconditioning or destruction of the products returned under the recall; and
  9. Take any other steps necessary in your judgment, or that your District requires.

NOTE: At this early stage there usually has not been a recall evaluation by the appropriate Center. In the absence of such an evaluation, avoid suggesting the firm extend its recall efforts.

7.2.2 - FOOD RECALLS

Experience with food recalls dictates specific information be obtained from firms which have used recalled material in the production of another product. This is necessary to decide if the recall must be extended to a new product(s). In those instances, the following are some areas to be covered:

  1. Incoming ingredient quality control procedures;
  2. Quality control over ingredients at the time of use, and the products in which the ingredients are used;
  3. A detailed description of the methods used in preparation and packaging of the processed product;
  4. How the finished product is stored and shipped;
  5. Labeling of product, and any cooking instructions for consumer or purchaser;
  6. Quality control testing of the finished product. Detail any test(s) performed by firm; and
  7. For products produced in USDA plants, determine if the USDA was notified of the suspect incoming ingredient? Did USDA determine what testing was done by the firm?

This information must be evaluated by CFSAN (HFS-607) prior to the initiation of any sub-recall.

7.2.2.1 - Interstate Milk Shippers

The FDA will not ordinarily be involved in the classification and auditing of Interstate Milk Shippers (IMS) product recalls where such actions have been, or are being, handled expeditiously and appropriately by the State(s). However, the FDA District office in which the recalling firm is located must be assured that all States involved in an IMS plant's recall are participating in ensuring removal of the product from commerce and that, when appropriate, States 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.

7.2.3 - MEDICAL DEVICE RECALLS Highlighted to denote updated text

Medical device recalls may result from manufacturing defects, labeling deficiencies, failure to meet premarketing requirements [PMA, 510(k)], packaging defects or other nonconformance problems. How firms identify the causes of medical device recalls and corrective action activities is essential to the analysis of medical device failures and the determination of the effectiveness of the medical device GMP program. It is also useful in evaluating the medical device program, and for directing attention to problem areas during inspections. 21 CFR Part 806.1 requires device manufacturers and importers to report certain actions concerning device corrections and removals. They must also maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA. (See 21 CFR Part 806.20). Failure to report as required by 21 CFR 806.10 is a violation and should be listed on the FDA-483, "Inspectional Observations." Center concurrence is required prior to issuing warning letters for suspected violations of the user reporting regulations; (806 is required for Manufacturers and Importers. Highlighted to denote updated text

Each device manufacturer or importer must submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer, if one was initiated:

  1. To reduce a risk to health posed by the device; or
  2. To remedy a violation of the Act caused by the device which may present a risk to health, unless the information has been provided according to 21 CFR 806.10 (f), or the correction or removal action is exempt from the reporting requirements under 21 CFR 806.1 Highlighted to denote updated text(b).

Collection of complaint, PMA and 510(k) related information is necessary to determine compliance with the GMP requirements. During recall follow-up inspections, answers should be obtained to the questions below, in addition to routine recall information. For firms where it has been established a manufacturing defect led to the recall, conduct a complete GMP evaluation of the manufacturing operations. Report such inspections into FACTS as "qualifying" GMP inspections.

7.2.3.1 - Problem Identification

  1. How did the firm identify the nonconformance which led to the recall (e.g., complaint, in-house data, etc.)?
  2. If the recall was due to a device defect, did the firm conduct a documented failure analysis of the device, using such techniques as fault tree or failure mode analyses? If so, report whether these results were provided for review.
    1. Did the firm determine the failure mechanism (e.g., shorted component, incomplete weld, etc.)?
    2. If not, how did firm determine the cause of the nonconformance?
    3. If not, what rationale does the firm have for not conducting a failure analysis?
  3. Did the firm determine at what phase of the device life cycle the nonconformance occurred (i.e., design, manufacturing, storage, use, etc.) and the actual cause of the nonconformance (i.e., software design error, process out of specifications, employee error, user misuse, etc.)? What evidence does the firm have to support the determination?
  4. Did the firm determine if the nonconformance resulted in an injury or death?
  5. If a component was responsible for the defect, determine if the same component was used in other devices manufactured by the firm. If so, has the firm conducted an analysis to assure the defect in the component will not have a deleterious effect on the operation of the other device(s)?
  6. If a component was responsible for the device defect, what other device manufacturers use the same com­ponent (and especially the same lot number of the component)? Has the manufacturer of the recalled device notified the component manufacturer? Has the component manufacturer contacted its other customers about the problem?
  7. Why was the component defective? Did the manufac­turer of the component change the specifications with­out notifying the finished device manufacturer? Did the component fail to meet its release specifications?

    NOTE: A visit to the component manufacturer may be needed to adequately answer questions 5, 6 and 7. Before doing so, confirm with CDRH and your super­visor that the matter is egregious enough to warrant this "next step."

  8. Did the finished device manufacturer have an incoming component/raw material sampling and testing proce­dure? If not, why not?
  9. If the manufacturer recalled the device because the labeling was inaccurate, or the wrong labeling was ap­plied to the device (label mix-up) determine the follow­ing:
    1. What quality system procedures should have been established to prevent the problem?
    2. If the label or instructions for use were inaccurate, was the inaccuracy introduced in the design stage, or was it due to a printing problem?
  10. If the device has been on the market for a year or more, and the manufacturer claims the problem is the result of design:
    1. Why is the problem just now showing up? How many reports concerning the problem did the firm receive before deciding a recall was necessary? Does the firm have a procedure established for de­termining if a recall is necessary, and if so, did it follow the procedure? Obtain a copy of the procedure.
    2. If the firm doesn't provide rational answers to the above questions, determine if they explored other possible causes for the problem.
    3. Was the design feature which caused the problem in­cluded in the design of the device that was the subject of a premarket submission?
    4. If the design feature which caused the problem is part of the original design, did the manufacturer re­call all products manufactured since the device was introduced to the market? If not, why not?
    5. If the problem was introduced via a design change, did the manufacturer follow established design change or change control procedures? If yes, are the procedures adequate? Was the nature of the problem such that it should have been anticipated, and the design verification/ validation study fash­ioned to detect the problem?
    6. Has the manufacturer recalled all products distrib­uted since the design change was introduced? If not, why not?

7.2.3.2 - Corrective Action

  1. Describe the corrective action taken to correct the immediate problem, e.g., redesign, modify SOP, process validation, etc.
  2. Did the firm qualify/validate the corrective action?
  3. Did the firm establish responsibility to assure that the corrective action would be implemented and satisfactorily completed?
  4. What action did the firm take to prevent recurrence of the nonconformance, e.g., training, increased process monitoring, etc.?
  5. Was the nonconformance information provided to those responsible for the areas in which the nonconformance occurred?
  6. Did the firm determine if the nonconformance extended to other devices?
  7. Did the firm determine if changes were needed in procedures and, if so, did it validate and implement the changes?
  8. Has the manufacturer taken appropriate corrective action?

7.2.3.3 - Complaint and Medical Device Reporting (MDR) Reporting

Determine if adequate complaint investigations were per­formed as required by 21 CFR 820.198(b). Also, determine if the investigation verified the complaint was a failure of the device to meet any or all of its specifications.

For complaints related to the recall, the firm should have made a determination whether the events are MDR reportable. Any event associated with a death or serious injury must be reported under MDR. Malfunctions likely to cause or contribute to a death or a serious injury are also reportable under MDR. Document the firm's explanations for the events they believe are nonreportable. Failure to submit required MDR reports are violations, and should be listed on the FDA-483 at the completion of the inspection.

Provide adequate documentation with the EIR to cross-reference complaints with associated MDRs.

Device Information - Obtain the 510(k) or PMA number for each device under recall. If there is no 510(k) or PMA, determine if the device is a pre-enactment device (i.e., in commercial distribution prior to May 26, 1976). If multiple devices are being recalled, obtain this information for each device model or catalog number under recall.

7.2.4 - DRUG RECALLS

7.2.4.1 - Recalls of Human Drug Products

If the recalled product is covered by a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), determine if the defective product involves the type of problems shown under CFR 314.81(b)(1)(i) and (ii). Also note whether or not the firm reported the problem to the FDA district office that is responsible for the firm within 3 working days of its receipt of the information, as required by that section.

7.2.4.2 - Recalls of Veterinary Drug Products

Veterinary Drug Products Recalls are classified by and health hazard evaluations are obtained through CVM's Division of Compliance (HFV-230), Eric Nelson, Director. To inquire about specific veterinary drug product recalls or to obtain information on how to proceed, contact the Division at 240-276-9200 or contact Kathy Hemming-Thompson at 240-276-9216.

7.2.5 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE BASED PRODUCTS (HCT/Ps) FOR IMPLANTATION, TRANS-PLANTATION, INFUSION, OR TRANSFER

The agency may consider an order of retention, recall, destruction, or cessation of manufacturing when any of the conditions specified in 21 CFR 1271.440(a)(1) to (3) exist. The conditions include an agency finding that:

  1. The HCT/P is infected or contaminated so as to be a source of dangerous infection to humans; or
  2. An establishment is in violation of the regulations in this part and, therefore does not provide adequate protections against the risks of communicable disease transmission.

In addition to the conditions noted above, the agency may issue an order of cessation of manufacturing until compliance with the regulations has been achieved, as stated in 21 CFR 1271.440(a)(3), when the FDA determines there are reasonable grounds to believe there is a danger to health. An order to cease manufacturing would be issued where violations create an urgent situation involving a communicable disease, because an establishment is in violation of the regulations in Part 1271 and, therefore, does not provide adequate protections against the risks of communicable disease transmission. An order to cease manufacturing is a remedial action taken to put important protections in place to prevent communicable disease transmission.

NOTE: FDA will not issue an order for the destruction of reproductive HCT/Ps, nor will FDA carry out such destruction itself (21 CFR 1271.440(f)).

7.2.6 - TOBACCO PRODUCT RECALLS

"To inquire about tobacco product recalls or to obtain information on how to proceed, contact the Center for Tobacco, Office of Compliance and Enforcement, Enforcement and Manufacturing Group. See CTP's intranet site for contact information."  http://inside.fda.gov:9003/CTP/ucm249908.htm

7.2.7 - SAMPLE COLLECTION

Collection of samples for regulatory consideration is at the discretion of District management. Consult your supervisor and/or compliance branch for guidance. If a sample is indicated, only collect documentary samples for electronic products or medical devices, unless otherwise instructed.

If, after consulting with the Centers, it is determined that a product must be examined physically for health hazard evaluation, ship an appropriate sample to the designated Center office by the most expeditious and practical means available. Notify the Center of the time and method you sent the product and its estimated time of arrival.

7.2.8 - RECALL ALERT Highlighted to denote updated text

When a District learns of or confirms a recall situation exists or is planned, the district R&E Coordinator Highlighted to denote updated text will send Highlighted to denote updated text the appropriate Center Recall Office and OEIO/DE Highlighted to denote updated text a twenty-four hour alert through the Recall Enterprise System (RES) with basic information regarding the recall Highlighted to denote updated text. See RPM Chapter 7-10, Attachment A, “Recall Alert Information.”

7.2.9 - RECOMMENDATION FOR RECALL NUMBER Highlighted to denote updated text

The district should prepare a memorandum, containing the recall recommendation Highlighted to denote updated text RPM Chapter 7-10, Attachment B as soon as possible. From the time the recall alert is sent to the appropriate Center, the district has five days to submit the Recall Recommendation (ten days if the recall is completed). Do not wait for writing, typing and submission of the EIR or investigative memorandum. If the memorandum is prepared by the Investigator, a copy of the memo should be attached to the EIR or investigative memo so the information need not be repeated in the body of the report. Highlighted to denote updated text

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Page Last Updated: 07/28/2015
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