FDA WARNING_LETTER - Bhavani Fruits & Vegetables LLC - October 30, 2017

On March 16, 2018, the FDA issued a Warning Letter to Bhavani Fruits and Vegetables LLC following an inspection from October 11-30, 2017. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117), resulting in adulterated food products under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Pest Exclusion (21 CFR 117.35(c)):** Evidence of rodent activity (gnaw holes, excreta, nesting material, live/dead mice) and bird activity (birds flying, landing on food, avian droppings) was observed throughout the warehouse. 2. **Plant Maintenance (21 CFR 117.35(a)):** Structural deficiencies like a 1-inch gap under the front rolling door, a 4-inch hole in the wall, and ripped/missing strip curtains in the rolling door and walk-in cooler were noted, allowing pest entry. While some repairs were made, sustained corrective actions were not provided. 3. **Food Storage (21 CFR 117.93):** Frozen products were stored on the floor, wet with condensate, covered in ice, and had collapsed boxes. Recyclable waste and