Lacteos Mi Chalatenango, Inc. – FDA Warning Letter, Mar 22, 2023

On June 12, 2023, the FDA issued a Warning Letter to Lacteos Mi Chalatenango following Foreign Supplier Verification Program (FSVP) inspections conducted from February 9 to March 22, 2023, and previously from August 22 to August 25, 2022. The inspections revealed significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, for imported foods.

As a very small importer, Lacteos Mi Chalatenango failed to obtain written assurances from foreign suppliers, as required by 21 CFR 1.512(b)(3), stating that food production meets U.S. food safety standards. This was a repeat observation from the August 2022 inspection. The firm also failed to respond to the Form FDA 483a FSVP Observations issued on March 22, 2023, and the previous one from August 25, 2022.

Furthermore, some imported products tested positive for *Staphylococcus Aureus*, leading to adulteration findings under section 402 of the FD&C Act. Specific products from two suppliers were placed on Import Alert #12-10 ("Detention Without Physical Examination of Cheese Due to Microbiological Contamination") in October 2022 and January 2023. The