Maintenance of Records Finalized in FSMA Regulation

The Establishment and Maintenance Rule become final for those companies in the U.S. who manufacture, process, pack, transport, distribute, receive, hold, or import food for humans or animals, and foreign persons who transport food in the U.S.  Here is a simplified version of the FDA guidance to help you identify what you need to know about records needed for food operations.

Of course, this should already be in place, much having been required as part of the Bioterrorism Act of 2002.

What are the record availability requirements?

When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, will cause serious adverse health consequences or death to humans or animals, any records or other information accessible to FDA must be made readily available for inspection and photocopying or other means of reproduction. These records must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice. 
The records may be kept in any format, paper or electronic, provided they contain all the required information.
The records requested may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such an article of food that are maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any location.