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FDA Draft Guidance – Initiation of Voluntary Recalls

This draft guidance is being distributed for comment purposes only; submit comments by 06/24/2019 (https://www.regulations.gov/document?D=FDA-2018-D-2074-0001).

Under 21 CFR 7, subpart C, the FDA lists guidance on policy, procedures, and industry responsibilities for recalls and product correction for voluntary recalls of products subject to FDA’s jurisdiction. The finalized draft guidance will help both industry and the FDA to be prepared for recalls so when necessary, the recalls are timely and effective. The FDA also discusses how the agency will aid firms in carrying out recall responsibilities.

The guidance shares information on how companies can be prepared for, establish procedures, and ensure timely identification of and response to product problems. The FDA also wants to work with companies so consumers can effectively be protected from potentially dangerous products.

The FDA has set new policies to swiftly post new recalls (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports) and this Enforcement Reports page will track and list recent recalls so consumers can protect themselves.

For assistance, you can contact an FDA ORA Recall Coordinator (https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators).

The Tentamus Group, in particular, Tentamus North America, offers various services to assist in ensuring your product is compliant and safe:

  • Product analysis for microbial and chemical safety
  • Product full label review for compliance
  • Product nutritional analysis and nutrition fact creation and review
  • Product Food Safety Plan/HACCP creation and consultation

The FDA Draft guidance on Initiation of Voluntary Recalls

can be found here: https://www.fda.gov/media/123664/download

Get in touch with our experts. We’re ready to discuss your requirements.


Vy Goddard, Regulatory Affairs Specialist

Tentamus North America


(540) 684-9211

Tentamus laboratories in your vicinity