FDA Issues Final Rule on Record Access Requirements
April 3, 2014 - Kestrel Food Safety
The U.S. FDA has issued its final rule on recordkeeping. This final rule adopts, without change, the interim final rule issued February 23, 2012.
- Allows FDA access to records beyond those relating to specific suspect food articles if the agency reasonably believes that other food articles are likely to be affected in a similar manner.
- Permit FDA to access records relating to articles of food where there is a reasonable probability that the use of, or exposure to, them will cause serious adverse health consequences or death to humans or animals.
The expanded records-access authority is designed to improve FDA’s ability to respond to and contain safety problems with the food supply for humans and animals.
- Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records
- Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
- Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
Submitted by: Bill Bremer