As FDA exercises its inspection authority under section 201 of the Food Safety Modernization Act (“FSMA”), it’s important to understand what records inspectors can/can’t ask for and to respond to overreaching with tact.
Section 201 requires FDA to conduct inspections for domestic food facilities based on risk. FDA developed a set of primary FSMA factors and a flowchart for identifying high-risk facilities, which are subject to a 3-year inspection cycle. Under FDA’s current approach, many facilities producing foods associated with outbreaks and/or recent Class 1 recalls would be considered high risk, regardless of whether the individual facility was itself affected by such a recall. As amended, section 414(a)(2) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) authorizes FDA to access records needed to determine if there is a “reasonable probability” the use of or exposure to an article of food (and any other article of food FDA reasonably believes is likely to be affected in a similar manner) will cause serious adverse health consequences or death to humans or animals when FDA believes there is a “reasonable probability” of the same.
The bases upon which FDA will determine that there exists a reasonable belief that articles of food are likely to be affected in a similar manner or that there is a “reasonable probability that the use or exposure… will cause serious adverse health consequences or death” remains unclear. FDA has explained that decisions on such questions “will be made on a case-by-case basis because such decisions are fact-specific.” Given the lack of guidance on these determinations, there is real concern that FDA will be more apt to cite this authority (despite FDA’s prior assurance that its new authority would be used “in a targeted fashion”) during routine inspections of facilities deemed high-risk by virtue of their producing foods associated with outbreaks and/or recent Class I recalls.
In addition to FDA’s authority under section 414(a), FDA has authority under section 103 of FSMA to review records evidencing compliance hazard analysis and preventive controls requirements.
In April, FDA issued a final rule and revised guidance documents on records maintenance and access authority under section 414. Facilities subject to the inspection and recordkeeping requirements under the revised FD&C Act should ensure they understand the regulatory recordkeeping requirements, which records are excluded, and determine whether/when it makes sense to request a Form 482c for records beyond the scope of FSMA section 103 (section 418 of the FD&C Act).