FDA WARNING_LETTER - Lett Us One Corporation - September 26, 2008

On September 23, 24, and 26, 2008, the FDA inspected Lett Us One Corporation's food processing facility in Caguas, Puerto Rico, to assess compliance with Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 110). The inspection revealed serious deviations, rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Violations included: 1. **Personnel Practices (21 CFR 110.10(b)(9))**: Employees were observed not wearing gloves during vacuum sealing, leaning into product bins with coats/broken sleeve protectors, and not removing coats in sanitary facilities. 2. **Glove Maintenance (21 CFR 110.10(b)(5))**: Employees touched non-food contact surfaces without sanitizing/changing gloves and reused gloves after breaks without changing them. 3. **Hair Restraints (21 CFR 110.10(b)(6))**: Employees with beards/mustaches were not wearing beard covers. 4. **Plant Maintenance (21 CFR 110.35(a))**: Water condensation and rust were observed on ceiling tiles above product, mold and condensation in the walk-in refrigerator, and a dirty, obstructed walk-in refrigerator floor.