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Focus on Regulation

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary recall.  Overall, FDA emphasizes the importance of pharmaceutical, biotechnology, medical device, food, tobacco, and animal products firms having made plans in advance of a recall so that they are prepared, should one become necessary.

How to be “Recall Ready”

In order to facilitate timely initiation of a voluntary recall, the draft guidance recommends firms make the following preparations:

  • Designate specific employees with recall-related responsibilities who possess the authority to take the steps needed to implement a product recall when necessary.
  • Train personnel on recall-related responsibilities, and consider additional preparatory steps such as mock recalls and establishing metrics appropriate to a recall plan.
  • Create a recall communications plan that identifies specific points-of-contact, and that contains draft templates that help the firm issue recall communications promptly.
  • Identify possible recall-associated reporting requirements, for circumstances when a significant problem with a distributed product may trigger a requirement to make a separate report to FDA, g., a report to the Reportable Food Registry or reports under 21 CFR 806 for medical devices.
  • Ensure adequate product coding to make possible positive lot identification and to facilitate the effective recall of all violative lots.
  • Maintain product 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 contain enough detail to identify the consignees that actually received the recalled product and must conform to any applicable requirements.

The draft guidance further advises a firm to maintain written recall initiation procedures that assign responsibility and describe the steps to perform all actions related to initiating a recall, as appropriate to the specific products and business model of the firm or facility.  These procedures should include actions such as (1) ceasing distribution, shipment or sales of affected product; (2) developing a recall strategy; (3) notifying direct consignees; and (4) when appropriate, notifying the public of the recall.

Steps for responding to an indication of a problem

The draft guidance outlines specific steps a firm should take if there is an indication of a problem with a distributed product:

  1. Identify the problem using indicators such as an internal report of a product specification deviation or out-of-specification testing results for a product.
  2. Promptly investigate the problem to ensure that potential risks are consistently assessed and investigated for products potentially affected.
  3. Make decisions about whether a recall is necessary, and if so, about the scope and depth of that recall.
  4. Consult with FDA about the problem, referencing the ORA recall coordinator list.

This draft guidance is part of a series of policy steps FDA is taking to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls, as we recently discussed in a February 26 alert.  FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said in a press release that “there is more that needs to be done,” adding that FDA “will continue its efforts to improve recalls, and will encourage the use of new technologies and other tools that can assist in those efforts.”

The voluntary recall draft guidance is open for public comment until June 24; please contact any of the above-listed authors if you have any questions about the guidance or may be interested in commenting.  We will continue to keep you apprised of new FDA efforts to inform companies on proper procedures for voluntary recalls.