Low-acid canned foods or acidified foods due to inadequate process control

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 10/21/2021 updates the guidance section. Changes to the import alert are bracketed by asterisks (***). FDA conducts inspections to ensure commercial processors of low-acid canned food (LACF) and acidified food (AF) products adhere to, among other things, the mandatory requirements of 21 CFR Part 108 and the LACF and AF Current Good Manufacturing Practices (CGMP) regulations under 21 CFR Parts 113 and 114. FDA also conducts field exams and sample analyses of LACF and AF products offered for entry. When establishment inspections, analytical results, field exams, or other data and information demonstrate that the products were not properly manufactured to control growth and toxin production from Clostridium botulinum or other microorganisms of significance to public health, FDA may subject the commercial processor and the affected products

Quoted from the “Reason for Alert” section of the FDA page for 99-38, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.