FDA Releases Draft Guidance on Voluntary Recalls

  • United States
  • 05/13/2019
  • Duane Morris LLP

May 13, 2019

As firms develop plans for voluntary recalls, we recommend that they consult with counsel to ensure that they comply with regulatory requirements and appropriately address the concerns raised by the FDA in this draft guidance.

The Food and Drug Administration (FDA) recently released a draft guidance on voluntary recalls urging companies to institute recall plans and procedures in advance to ensure quick and effective execution when a recall is necessary: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA broke the guidance into four main parts: (1) preparation for a recall; (2) response to a reported problem with a product; (3) initiation of a recall; and (4) FDA’s role in initiation of a recall. As firms develop plans for voluntary recalls, we recommend that they consult with counsel to ensure that they comply with regulatory requirements and appropriately address the concerns raised by the FDA in this draft guidance.

Preparation for a Recall

Personnel

The FDA recommends that specific personnel should—and sometimes must—be assigned responsibilities and authority in the event of a recall. In determining whom to task with these roles, the company should consider the need for alternate employees as well as a “recall team” if the complexities of the product distribution demand. Companies must also train personnel to carry out these tasks.(continue)

Read the full text at https://www.duanemorris.com/alerts/fda_releases_draft_guidance_voluntary_recalls_0519.html