Gold Coast United, Inc. – FDA Warning Letter, Jun 12, 2012

The FDA inspected Gold Coast United, Inc.'s manufacturing facility in Elkridge, Maryland, from June 1-12, 2012, revealing insanitary conditions and serious violations of 21 CFR Part 110 – Current Good Manufacturing Practice (CGMP) for human food. Consequently, their tofu and soy milk products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to wash and sanitize hands:** Employees did not wash or sanitize hands/arms before starting work, after absences, or when soiled, specifically observed touching discolored strip curtains and equipment before handling raw and ready-to-eat (RTE) tofu/soy milk. One employee submerged bare arms into an RTE tofu cooling tank without prior washing. [21 CFR 110.10(b)(3)] 2. **Improper glove maintenance:** Reusable latex gloves were not maintained in a clean and sanitary condition; employees did not wash/sanitize them after touching contaminated surfaces before handling food. [21 CFR 110.10(b)(5)] 3. **Contaminated food contact surfaces:** Plastic tools used for RTE soy milk and tofu had yellowish discoloration and numerous gouges, failing to protect food from contamination. [21 CFR 110.40(a)] 4.