By Mark Durivage, Quality Systems Compliance LLC
The FDA’s Office of Regulatory Affairs, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and Radiological Health issued Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff on March 4, 2022. This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance finalizes the draft guidance of the same title issued on April 24, 2019 (84 FR 17112). The FDA considered the public comments received pertaining to the draft guidance. Editorial changes were made to enhance clarity.
Changes from the draft to the final guidance included the addition of the following terms:
- Correction is the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.
- Market withdrawal is 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.
The FDA recommends that firms in the distribution chain prepare by becoming recall ready. Firms are encouraged to identify appropriate personnel, train personnel on their responsibilities, establish a recall communications plan, identify any FDA required reporting requirements for distributed products, use adequate product coding, and maintain distribution records.
The guidance suggests that firms consider preparing, maintaining, and documentation procedures for initiating a recall and performing actions related to initiating a recall. The procedures for initiating a recall and performing actions related to initiating a recall should define the responsibilities and describe the required process to perform all appropriate actions, including ceasing distribution, shipment, and/or sales of affected product(s), developing a recall strategy, notifying direct accounts about the product being recalled, including what should be done with respect to the recalled product, providing response instructions to notified direct accounts, including instructions for appropriate disposition of recalled product, and when appropriate, notifying the public about products that present a health hazard.
Certain products (human cell, tissue, and cellular and tissue-based products, medical devices, and drug products) have specific regulatory requirements related to identifying, investigating, and reporting product problems. While compliance with regulatory requirements is necessary, the FDA also recommends that all firms identify the problem, investigate the problem, make decisions and take action, and consult with the FDA about the problem.
Initiating A Recall
Once a firm has decided to initiate a voluntary recall using established procedures, all affected product in the firm’s direct control should be quarantined and the original consignees should be notified about the recall by mail, email, issuing a press release, and other public notice, including social media and the firm’s website. The original consignees should also quarantine any product under their direct control and, where possible, notify their consignees. The FDA considers the date the firm first communicates about a recall to original consignees or to the public to constitute the date of initiation.
Coordinating With The FDA
Firms located in the United States should contact a Division Recall Coordinator within the FDA Office of Regulatory Affairs (ORA). Firms located outside of the United States that are recalling a product exported to the United States should contact ORA headquarters at firstname.lastname@example.org. Additionally, the FDA may contact a firm and initiate discussions about a product problem. The FDA may request a recall based on the following: a product that has been distributed presents a risk of illness or injury or gross consumer deception, the firm has not initiated a recall of the product, and agency action is necessary to protect the public health and welfare.
The FDA is committed to working collaboratively whenever possible to facilitate the orderly and prompt removal of recalled products. FDA Recall Coordinators provide firms with information about the recall process and are available to work closely with the firm throughout the course of the recall process. FDA Recall Coordinators can assist in recall determination, developing an appropriate recall strategy, reviewing the recall communications, and with monitoring the destruction, reconditioning, or disposition of the recalled product.
During an FDA-requested recall, the firm may be asked to provide the FDA with additional information, including the identity of the product involved, the reason for the removal or correction, the date and circumstances under which the product deficiency or possible deficiency was discovered, and additional information as required. When the firm agrees to recall the product based on FDA’s request, the action is still considered a voluntary recall.
In the event that a recalling firm’s actions do not adequately protect the public from a violative product, the FDA may consider taking other appropriate actions. However, it is also in the firm’s best interest to fully cooperate with the FDA.
Prepare With Mock Recalls
Recalls can be very stressful. Proper preparation is crucial. I cannot stress enough the importance of conducting mock recalls considering a raw material, finished devices, and products produced or tested with a particular piece of equipment. The mock recall should be fully documented, timed, and include a postmortem analysis of the process to identify weaknesses, opportunities for improvement, and best practices. Additionally, others besides the designated primary individuals should participate to ensure backup or substitute personnel understand the process and can perform the assigned tasks in the absence of the primary individuals. A word of caution: Ensure that any participating original consignees are fully advised the exercise is a mock recall and not an actual recall.
Hopefully, the mock recall exercise is the only time the process will be tested!
You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-D-2074.
About the Author:
Mark Allen Durivage has worked as a practitioner, educator, consultant, and author. He is managing principal consultant at Quality Systems Compliance LLC, an ASQ Fellow, and SRE Fellow. He earned a BAS in computer aided machining from Siena Heights University and an MS in quality management from Eastern Michigan University. He holds several certifications including CRE, CQE, CQA, CSQP, CSSBB, RAC (Global), and CTBS. He has written several books available through ASQ Quality Press, published articles in Quality Progress, and is a frequent contributor to Life Science Connect. Durivage resides in Lambertville, Michigan. Please feel free to email him with any questions or comments.