Lacteos Mi Chalatenango, Inc. Warning Letter Details

Summary

Lacteos Mi Chalatenango, Inc., a food importer based in Saint Paul, Minnesota, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation required under section 805 of the Federal Food, Drug and Cosmetic Act. During inspections conducted from August 2022 through March 2023, the FDA identified that the company, operating as a very small importer, did not obtain required written assurance from foreign suppliers confirming compliance with U.S. food safety standards before importing food and at least every two years thereafter, as mandated by 21 CFR 1.512(b)(3). The company did not respond to the FDA 483a form issued on March 22, 2023, documenting these significant violations.