FDA Issues Recordkeeping Guidance on Food Distribution

The Food and Drug Administration (FDA) has issued updated industry guidance “pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food.” Although this fifth edition is effective immediately, FDA welcomes comments at any time.

Requiring records that identify “immediate previous sources and the immediate
subsequent recipients of food” along the food-distribution chain, FDA
has been given expanded authority by the Food Safety and Modernization
Act of 2011 to “access records relating to foods that may cause serious adverse
health consequences or death to humans or animals.” Although the guidance
incorporates these statutory changes, it has not deviated much from
the fourth edition released in September 2006, FDA said. Rather, it provides
practical information on such topics as records requirements, retention
and availability, and “the consequences of failing to establish and maintain
required records or failing to make required records available to FDA.” See
Federal Register, February 23, 2012.