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ContentsSUBCHAPTER 800 - RECALLS801 - DEFINITIONS 801.01 - Recall 801.02 - Medical Device Notification 801.03 - Medical Device Safety Alert 801.04 - Human Tissue for Transplantation SUBCHAPTER 810 - RECALL NOTIFICATION / INSPECTION 810 - INSPECTION PROCEDURES 810.01 - Recall Decision Follow-up 811 - FOOD RECALLS 811.01 - Interstate Milk Shippers 812 - MEDICAL DEVICE RECALLS 813 - DRUG RECALLS 813.01 - Recalls of Human Drug Products 813.02 - Recalls of Veterinary Drug Products 814 - SAMPLE COLLECTION 815 - RECALL ALERT 816 - RECOMMENDATION FOR RECALL NUMBER SUBCHAPTER 820 - MONITORING RECALLS 821 - INSPECTIONS TO MONITOR RECALL PROGRESS 822 - FDA RECALL AUDIT CHECKS 822.01 - Definition 822.02 - Level of Audit Checks 822.03 - Sub-Account Checks 822.04 - Conducting the Check 822.05 - Audit Check Reporting 822.06 - Ineffective Recalls 823 - RECALL TERMINATED / RECALL COMPLETED 823.01 - Definitions 823.02 - Closeout Inspection SUBCHAPTER 830 - SPECIAL RECALL SITUATIONS 830 - General SUBCHAPTER 800 - RECALLS801 - DEFINITIONS801.01 - RecallA Recall is a firm's removal or correction of a marketed product that FDA 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 a stock recovery. See the Agency recall policy outlined in 21 CFR 7.1/7.59 - Enforcement Policy - General Provisions, Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities. Recall Classification - Means the numerical designation, i.e., I, II, or III, assigned by the FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. There are three possible classifications. Class I - 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 - 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 - A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. Recall Type - A designation based on whether the recall is Voluntary, FDA Requested (at the request of the Commissioner or his designee), or ordered under section 518(e) of the FD & C Act [21 U.S.C 360h (e)]. Recall Strategy - A planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall. Depth of Recall - Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, i.e., wholesaler, retailer, user/consumer. Recall Number - Number assigned by a responsible Center for each recalled product they initiate. This number consists first of a letter designating the responsible Center (see letter Codes below), a 3-digit sequential number indicating the number of recalls initiated by that Center during the fiscal year, and a 1-digit number (the Center for Devices and Radiological Health (CDRH) uses 2-digit numbers) indicating the fiscal year the recall was initiated. For example: F-100-2 identifies the 100th recall initiated by the Center for Food Safety and Applied Nutrition (CFSAN) in FY-2002. The following letters are used to identify the Centers.
801.02 - Medical Device NotificationNotification Order - An order issued by FDA requiring notification under section 518(a) of the FD & C Act [21 U.S.C. 360h (a)]. The directive issues when FDA determines a device in commercial distribution, and intended for human use, presents an unreasonable risk of substantial harm to the public health. The notification is necessary to eliminate the unreasonable risk of such harm, and no more practicable means is available under the provisions of the Act to eliminate such risk. Notification - A communication issued by the manufacturer, distributor, or other responsible person in compliance with a Notification Order. It notifies health professionals and other appropriate persons of an unreasonable risk of substantial harm to the public health presented by a device in commercial distribution. 801.03 - Medical Device Safety AlertThis is a communication voluntarily issued by a manufacturer, distributor, or other responsible person (including FDA). It informs health professionals and other appropriate persons of a situation which may present an unreasonable risk to the public health by a device in commercial distribution. NOTE: Medical Device Notifications and Safety Alerts as described in IOM 801.02 & 801.03 are to be handled by the Districts as recalls. They will go through the stages of alert, recommendation, classification, field notification, firm notification letter, firm effectiveness checks and status reports, FDA audit checks, and termination recommendations. 801.04 - Human Tissue for TransplantationFDA may issue an order for recall, retention, and destruction of human tissue intended for transplantation upon a finding the tissue may be in violation of the regulations in 21 CFR 1270. However, firms are usually afforded an opportunity to take corrective actions voluntarily. The procedures for recall, retention, and destruction in 21 CFR 1270.43 will be used when the FDA finds it necessary to ensure the suitability of human tissue for transplantation. FDA intends to invoke this section when there is evidence a tissue establishment failed to voluntarily address a violation related to tissue suitability, such as the source of the human tissue, the adequacy of the testing or screening of the human tissue, or the adequacy of donor selection. (See 21 CFR Part 1270.43).SUBCHAPTER 810 - RECALL NOTIFICATION / INSPECTION
If FDA learns of a questionable product which may lead to a recall, an inspection is made to determine the firm's course of action. This inspection should include a determination of the underlying or, root cause(s) of the problem(s). 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. 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 and repairs, etc. 810 - INSPECTION PROCEDURESAn 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 reoccurring. 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:
810.01 - Recall Decision Follow-upIf the firm has decided to recall, do the following:
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. 811 - FOOD RECALLSExperience 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:
This information must be evaluated by CFSAN (HFS-607) prior to the initiation of any sub-recall. 811.01 - Interstate Milk ShippersThe 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. 812 - MEDICAL DEVICE RECALLSMedical device 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. 21CFR 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 806.1). Failure to report as required by 21 CFR 806.1 is a violation and should be listed on the FDA-483, "Inspectional Observations." This may be included in a direct reference Warning Letter. 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:
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. Problem Identification
Corrective Action
Complaint and Medical Device Reporting (MDR) Reporting
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. 813 - DRUG RECALLS813.01 - Recalls of Human Drug ProductsIf 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.813.02 - Recalls of Veterinary Drug ProductsVeterinary Drug Products Recalls are classified by and health hazard evaluations are obtained through CVM's Division of Compliance (HFV-230), Gloria J. Dunnavan, Director. To inquire about specific veterinary drug product recalls or to obtain information on how to proceed, contact the Division at (301) 827-1168 or contact Barbara Rodgers at (301) 827-0356.814 - SAMPLE COLLECTIONCollection 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. 815 - RECALL ALERTWhen a District learns of or confirms a recall situation exists or is planned, they will give the appropriate Center Recall Office and OE/DCMO (HFC-210) a twenty-four hour alert. See Chapter 7 of the RPM.816 - RECOMMENDATION FOR RECALL NUMBERA memorandum should be prepared as soon as the recall number is available, and transmitted to your District's R&E Coordinator through your Supervisor. Do not wait for writing, typing and submission of the EIR. A copy of the memo may be attached to your EIR as an exhibit, so the information need not be repeated in the body of the report. 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). See Attachment B to Chapter 7 of the RPM.
SUBCHAPTER 820 - MONITORING RECALLS821 - INSPECTIONS TO MONITOR RECALL PROGRESSIt may be necessary to re-inspect the firm between the initiation and closeout of a recall to monitor its progress and verify the recalled product's disposition. These visits are limited inspections; issue an FDA-482, Notice of Inspection, at each one. Request recalling firms to submit periodic status reports to FDA . See 21 CFR 7.53.822 - FDA RECALL AUDIT CHECKS822.01 - DefinitionA recall audit check is a personal visit, telephone call, letter, or a combination thereof, to a consignee of a recalling firm, or a user or consumer in the chain of distribution. It is made to verify all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action.822.02 - Level of Audit ChecksLevel A - 100% of the total number of consignees to be contacted. Level B - Greater than 10% but less than 100% of the total number of consignees to be contacted. Level C - 10% of the total number of consignees to be contacted. Level D - 2% of the total number of consignees to be contacted. Level E - No effectiveness checks. NOTE: A statistical audit plan may be directed by the Center involved. 822.03 - Sub-Account ChecksIf a recall strategy includes sub-recall by a firm's direct accounts, sub-recall checks will be made following the above levels, as instructed by the Center and your supervisor.822.04 - Conducting the CheckYour assignment contains the necessary details of the recall, recall strategy, and a list of accounts to be checked. The Center will indicate how checks will be made, i.e., visit, phone calls, record checks, etc. Obtain at least the following information, plus any additional information requested by the monitoring district or your home District:
When you conduct an audit check by visit, you should visit the storage sites for the recalled product and check the shelf stock to ensure all recalled product has been identified, removed from areas of use and properly quarantined. In firms where products are stored in multiple locations, a sufficient number should be checked to verify the consignee properly found and removed all product subject to the recall. This is especially important in Class I recalls and you should check each storage site. 822.05 - Audit Check ReportingThe narrative results of your audit check should be reported on an FDA 3177, "Recall Audit Check Report" form. See IOM Exhibit 820-A. Districts have the option of using computer generated audit check forms or hard copies. The FDA 3177 is a three-part form, which is basically self-explanatory. If necessary, instructions for completing it may be found in RPM, Chapter 7, Exhibit 7-8. It is distributed as follows: Original - Monitoring district. Yellow Copy - Accomplishing district files. Pink Copy - District Use Version 2 of FACTS allows you to enter the amount of time and other data information. When you complete Recall Audits, you should report your time using the "Miscellaneous Operations Accomplishment Hours" screen. You do not need to report the information on the 3177 unless your District SOP requires this. Until some other reporting procedure is developed, continue to report audit checks using the FD-3177 form or memorandum. 822.06 - Ineffective RecallsIf your audit check discloses recalled product being held for sale, or a requested sub-recall has not been initiated, document the responsibility for failure to follow recall instructions. This is particularly important if the account received the recall notice and ignored it. An Official Sample should be collected from these remaining products. If in doubt, contact your supervisor or R&E Coordinator. Encourage the consignee to follow the recalling firm's instructions. If a sub-recall is justified, obtain a commitment and details of the firm's sub-recall effort. Get distribution information for follow-up sub-account audit checks.823 - RECALL TERMINATED / RECALL COMPLETED823.01 - DefinitionsRecall Terminated - A recall will be terminated when the FDA determines that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product. Written notification that a recall is terminated will be issued by the appropriate District office to the recalling firm. Recall Completed - For monitoring purposes, the FDA classifies a recall action "Completed" when all outstanding product, which could reasonably be expected is recovered, impounded, or corrected. 823.02 - Closeout InspectionThe final monitoring step is a limited inspection made to verify recall closeout by the recalling firm. A memorandum or limited EIR should be prepared. See Attachment D of Chapter 7 of the RPM for the format. Portions of this format (i.e., Section II and certain items in Section III) will be completed by your supervisor, R&E Coordinator, or compliance officer, depending upon your District's policy. During the closeout inspection, you should witness destruction or reconditioning of the recalled product when possible. If you are unable to witness the destruction or reconditioning, obtain written documentation from the firm and/or any state or local government agencies which may have witnessed or otherwise verified product disposition. The disposal of large amounts of contaminated or hazardous items may require the firm to file an Environmental Impact Statement (EIS), or pre-disposal processing to render the goods harmless. Do not agree to witness destruction without resolution of these issues. Obtain a "Letter of Voluntary Destruction" from the firm whenever you witness this operation. See IOM 749.01. SUBCHAPTER 830 - SPECIAL RECALL SITUATIONS830 - GeneralThere are several special recall situations which may require you to deviate from the normal recall procedures. Seek your supervisor's or R&E Coordinator's guidance on these. Examples include:
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