FDA WARNING_LETTER - Charanga Catering, LLC dba Broche III - July 02, 2014

On August 28, 2014, the FDA issued a Warning Letter to Charanga Catering, LLC dba Broche 3 following an inspection from May 23 to July 2, 2014. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110). These violations render their fried swai fillets, baked salmon fillets, mixed seafood ceviche, and non-fishery ready-to-eat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plans:** No HACCP plans for fried swai fillets, baked salmon fillets, or mixed seafood ceviche to control hazards like allergens, pathogen growth, and survival through cooking. The firm's response of an "incomplete" plan was deemed inadequate. 2. **Inadequate Sanitation Monitoring:** Failure to sufficiently monitor sanitation conditions, including water safety (no backflow devices), lack of hot water/hand drying at sinks, employee personal items near food, stagnant water, improper handwashing, condensate dripping onto food, incorrect sanitizer concentration, and pest infestation (live insects). 3. **Pest Exclusion Failure:** Evidence of rodent filth in food processing and storage areas, and