FDA WARNING_LETTER - Tropical Bakery Wholesale - June 03, 2010

On October 5, 2010, the FDA issued a Warning Letter to Tropical Bakery Wholesale following an inspection from May 26 to June 3, 2010. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering bread products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations included: 1. **Pest Control (21 CFR 110.35(c)):** Observations of live flies on bread dough and equipment, a live roach, a dead fly on finished bread, and a live bird flying in the processing area eating dough. 2. **Pest Harborage (21 CFR 110.20(a)(1)):** Accumulation of discarded boxes, bags, debris, and cluttered equipment near the plant. 3. **Pest Exclusion (21 CFR 110.20(b)(7)):** Gaps under doors, an open bay door, and an open screen door during production. 4. **Contamination Prevention (21 CFR 110.10(b)(9)):** Employee perspiration contacting dough, unwashed hands touching dough after dirty equipment, dough contacting rusted cart legs, unsanitized knife use, cross-contamination from lard box, unbag