This week FDA released its proposed new rule on Records Access along with updated draft guidance document regarding the rule. The rule updates the existing regulations and guidance to note FDA’s expanded access to records in certain circumstances under FSMA. Under the Bioterrorism Act, FDA already had expanded records access under Class I recall-type situations; the rule expands access to records for other products reasonably likely to be similarly affected (e.g. if Salmonella is found in a finished product in product line A, FDA may have access to records for product line B if it has a reasonable belief product line B products are similarly affected). The interim rule and draft guidance document are available on FDA’s FSMA website.
This is just a taste of what is to come. We expect to see additional rules and guidance on recordkeeping requirements and records access provisions as FDA continues to implement FSMA. Questions on what records you need to be keeping or what sort of records FDA may access during an inspection? Contact Sarah Brew or another member of our Food Litigation and Regulatory Team.