FDA WARNING_LETTER - BULCONS PARVOMAY AD - September 09, 2014

On December 15, 2014, the FDA issued a Warning Letter to BULCONS PARVOMAY AD, a low-acid canned food (LACF) and acidified food processing facility in Bulgaria, following an inspection on September 8-9, 2014. The inspection revealed serious violations of 21 CFR Parts 113 (LACF) and 114 (Acidified Foods).

Key violations included: 1. **Lack of Temperature Recording Devices:** Six still water retorts lacked temperature recording devices for LACF products (21 CFR 113.40(b)(2)). Acidified food records also lacked sufficient thermal processing information (21 CFR 114.100(b)). The firm's response, indicating a new system by October, was inadequate as it didn't address interim product processing. 2. **Lack of Water Level Indicators:** The same six retorts lacked water level indicators (21 CFR 113.40(b)(9)), preventing assurance that every acidified food container was immersed for sufficient thermal processing (21 CFR 114.80(a)(1)). The firm's response was similarly inadequate regarding interim measures. 3. **Inadequate Container Coding:** LACF product container codes only contained expiration and batch numbers, failing to identify the establishment, product, year, day, and period packed (