Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions

Why FDA issued it

NOTE: The revision of this import alert (IA) dated 08/15/2025 updates the guidance section to include additional clarification on analytical evidence, processing products subject to the import alert, and the product description section. Changes to the IA are bracketed by asterisks (***) This major revision is associated with updates to the red list for firms previously listed under IA 12-10 noted to have staph aureus violations subject to the 402(a)(4) charge. In September 2015, the U.S. Food and Drug Administration (FDA) published regulations for human foods that set out new requirements to enhance the safety of the food supply. FDA's Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, under Title 21, Code of Federal Regulations (CFR), Part 117 (21 CFR Part 117) modernized the existing good manufacturing practices (GMP) requirements a

Quoted from the “Reason for Alert” section of the FDA page for 99-43, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.