Get Back to Where You Once Belonged: FDA Issues Final Guidance on Initiating Voluntary Recall

In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials might have watched the series (or are familiar with the song) because, this month, it issued a final guidance for industry and FDA staff called “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.”¹ FDA issued a draft guidance with the same title on April 24, 2019. In addition to editorial changes, the final guidance includes language that promotes the use of electronic communications when conducting a recall of FDA-regulated products.

The guidance describes how companies can recall, or get back, violative products. Specifically, the guidance addresses:

1. how to prepare for and initiate timely voluntary recalls of FDA-regulated products; and
2. how those companies in a distribution chain can prepare to maximize such timely responses to a recall communication; and describes where FDA will assist companies with executing their recall responsibilities.

The guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and medical device intended for human or animal use; any cosmetic and biological product intended for human use; any tobacco product intended for human use; and any item subject to a quarantine regulation.²

Interested parties may submit comments at any time.

This Bulletin highlights some key points described in the guidance and offers AGG observations.

Highlights

General Considerations

• FDA suggests that companies prepare in advance — or as the guidance puts it, be “recall ready” — before they are put in a position of considering initiating a voluntary recall, and offers the following recommendations to maximize timelines and efficiency.
  • Identify appropriate personnel to handle recall-related responsibilities.
  • Consider alternate personnel and a “recall team,” and train them on their responsibilities, prepare a mock recall, and evaluate the company’s recall readiness and potential ways to improve.
  • Establish a recall communication plan to address internal communications, communications with FDA, and communications to direct accounts (i.e., first consignee in a company’s distribution chain) or the public; prepare draft templates that help the company issue recall communications promptly (FDA has model recall communication templates on its website).
  • Use electronic communications for providing voluntary recall communications where possible.
  • Identify any reporting requirements for distributed products that might be subject to a recall, such as a report to the Reportable Food Registry, an adverse event report for a dietary supplement, a Field Alert Report for a distributed human or animal drug product, a report of a product deviation associated with the manufacturing of certain biologics, and a report in advance of a discontinuance or interruption in a company’s or facility’s production of a life-saving drug that is likely to lead to a meaningful disruption in the supply of that drug.
  • Use adequate product coding, such as a “product identifier” for human prescription drugs or a unique device identifier on labels and packages.
  • Provide sufficient coding to improve lot identification and facilitate the effective recall of affected lots.
  • Maintain distribution records, such as distribution requirements for finished medical devices, product tracing requirements for certain human prescription drug product transactions, and distribution and receipt records for blood and blood products.
  • Keep distribution records for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention; the records should include the direct accounts that received the recalled product by name, physical address where the product was delivered, and a contact telephone number.
• Any direct accounts that further distribute the product should maintain records of their own direct accounts to ensure that the recalling company’s instructions are extended to all consignees in the distribution chain.

Recommended Procedures for Initiating and Performing a Recall

• FDA recommends that companies prepare, maintain, and document written procedures (paper or electronic format).
  • A company should include written recall procedures into its training for personnel.
  • For consignees (i.e., anyone who reviewed, purchased, or used the product being recalled), FDA notes that these procedures may help extend the recall throughout the distribution chain.
  • A company’s written recall procedures should include who is responsible for what and the steps to perform all actions, including stopping distribution, shipment, and sales of the affected product; developing a recall strategy (including the possibility that the scope of the recall may expand if additional lots or products are affected); and notifying direct accounts about the product being recalled, including what should be done with respect to the recalled product (and might include instructing the direct account to further notify its own direct accounts about the recall).
• FDA encourages the use of electronic communications for providing voluntary recall communications.
• If the communications plan specifies a contact of a direct account by telephone, the recall communication plan should include the telephone communication in writing (e.g., follow up the telephone call with a written or electronic communication) and document the telephone communication.
• A company should send response instructions to notified direct accounts, such as instructions for the method (e.g., written response form, telephone call, or electronic communication) that the direct account can use to respond to the notification, and should include points of contact for follow-up communication at the recalling company.
• The firm should include instructions for appropriate disposition of recalled product; the company should provide its direct accounts with instructions regarding appropriate disposition of recalled product (e.g., return or destruction of the product).
• If appropriate, the company should notify the public about a product that presents a health hazard.
• A company should conduct a timely investigation to determine whether a deviation in manufacturing occurred and, as applicable, whether the safety, effectiveness, purity, or potency of distributed products may have been affected or whether a product may be adulterated or misbranded.
• A qualified person, following established criteria, should ensure that potential risks are adequately assessed and investigated for products potentially affected.
• FDA makes clear that a recalling company should not delay initiation of a voluntary recall while it is completing the investigation.
• A company’s procedures should establish that it takes steps to ensure that decisions are made to control defective and potentially harmful products in a timely manner, including deciding whether to initiate a voluntary recall and the appropriate scope of the recall, (e.g., the groups of units to be recalled as identified by product coding or, in instances where the product does not bear a code, a description of the units distributed within a specific date range or period of time).
  • The appropriate depth of the recall (i.e., depending on the product’s degree of hazard and extent of distribution, the company’s recall strategy should specify the level in the distribution chain to which the recall is to extend the need to discontinue production and distribution of affected product).
• When consulting with FDA, a company should promptly notify each of its affected direct accounts about the recall and issue a press release or other public notice, if appropriate; FDA considers the date of a company’s first communication about a recall, either to its direct accounts or to the public, to constitute the date of initiation.
  • The company should follow the initiation procedures in its plan to implement the recall in accordance with FDA requirements.
  • FDA will review (and comment, if appropriate) on the content of the proposed communications.
  • A company should not delay initiation of a voluntary recall while FDA is reviewing its recall strategy or recall communications.
  • A company should identify the level in the distribution chain to which the recall is to extend and provide instructions to direct accounts to extend the recall to their own direct accounts if the product could have been further distributed.
  • A recipient of a recall communication should implement its own recall initiation procedures to extend the recall promptly to its direct accounts that may have received the affected product, in accordance with the instructions received from the recalling company; follow-up communication should occur for any direct account that fails to respond to a recall communication to ensure the direct account has received and understands the recall communication.
• FDA recall coordinators are located throughout the country.
  • The coordinators may, among other things, help companies with recall strategy; review a recalling company’s communications to direct accounts or to the public about the recall; and monitor the destruction, reconditioning, or disposition of the recalled product.
  • A company located in the U.S. should contact a Division Recall Coordinator within the FDA Office of Regulatory Affairs; if the company is located outside of the U.S. and is recalling a product exported to the U.S., the recalling company should contact ORA headquarters.
• FDA may contact a company if it determines that a distributed product violates the law, recommending that it cease distribution and recall the product.
• If the company voluntarily decides to recall the product, it is considered a company-initiated voluntary recall.
• An FDA-requested recall may be initiated if:
  • a product that has been distributed presents a risk of illness or injury or gross consumer deception;
  • the company has not initiated a recall of the product; and
  • an agency action is necessary to protect the public health and welfare.

AGG Observations

• It is clear that FDA wants “timely” recalls and is expecting companies to prepare in advance to maximize this timeliness, such as conducting training, having recall procedures in place, conducting internal audits and making appropriate improvements, and drafting a communications plan, among other considerations.
• FDA expects that others in the distribution chain will be prepared to move quickly; the recalling company needs to ensure all parties are ready in advance to execute a timely recall
• The agency offers its assistance where it can, and a company should work with FDA to facilitate the recall.
• A company’s preparation for a possible recall should include establishing methods and procedures to gather information that will demonstrate to FDA the effectiveness of the company’s recall effort.

FDA wants companies to get back products unlawfully sold and distributed; it does not want to “let it be.”

[1] While a guidance document is not legally binding on FDA or industry, it represents the agency’s current thinking. The document can be accessed at www.fda.gov/media/123664/download.

[2] It does not apply to electronic products subject to 21 C.F.R. Parts 1003 and 1004.