- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Regulatory AffairsCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Food Safety and Applied NutritionCenter for Tobacco ProductsCenter for Veterinary Medicine
The purpose of this draft guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, Subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-2074.