FDA WARNING_LETTER - Midwest Foods, LLC - December 13, 2023

On May 21, 2024, the FDA issued a Warning Letter to a ready-to-eat (RTE) food manufacturing facility in Ankeny, IA, following an inspection from December 11-13, 2023. The inspection revealed significant violations of the Acidified Foods regulation (21 CFR Part 114) and Emergency Permit Control regulation (21 CFR Part 108) for products including salsas, sauces, dressings, and jams. These violations render the acidified food products adulterated under 21 U.S.C. § 342(a)(4).

Specific violations include: 1. **Failure to file scheduled processes:** The firm did not file scheduled processes with the FDA for 12 or 16 oz. Kramer’s Salsa Medium, or 16 oz. Kramer’s Salsa Inferno or Kramer’s Habanero Salsa XXXtreme. While a filing for 15.5 oz. Kramer’s Habanero Salsa XXXtreme was received, other sizes remain unfiled. 2. **Failure to process in conformity with scheduled processes:** Deviations were noted for 32 oz. Kramer’s Salsa Medium (cook hold time and fill temperatures) and for Kramer’s Salsa Medium and Salsa Inferno (lack of documentation for inversion time). The firm's response did not confirm that affected products were rendered safe.

Additionally,