FDA WARNING_LETTER - Repostería Aymat, Inc. - May 12, 2011

The FDA conducted an inspection of Repostería Aymat, Inc. from May 4-5 and 12, 2011, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, Donas Glaceadas Aymat products were found to be misbranded under Section 403 of the Act and 21 CFR Part 101.

Key violations include: 1. **Equipment and Utensil Maintenance (21 CFR 110.80(b)(1)):** Rust on an industrial mixer impeller, bins with old food residues, and proofing cabinet trays with grease/dirt were observed. Cleaning methods were inadequate (e.g., only hot water for mixer, wet rag for trays). Cooling fans blowing over unprotected donuts were covered in dust. 2. **Employee Hygiene - Hand Washing (21 CFR 110.10(b)(3)):** An employee touched food dough with bare hands after touching tools, utensils, and water without washing/sanitizing. 3. **Employee Hygiene - Gloves (21 CFR 110.10(b)(5)):** An employee touched their forehead, clothes, and equipment with gloves before handling