FDA WARNING_LETTER - Wagner Provisions Co., Inc - September 29, 2011

On January 6, 2012, the FDA issued a Warning Letter to Wagner Provisions Company, Inc. following an inspection from September 21-29, 2011. The inspection revealed significant violations for the manufacturer and distributor of acidified food products, specifically "Herb's Pickled Sour Onions" and "(b)(4) Sour Onions."

The firm failed to comply with 21 CFR 108 (Emergency Permit Control) and 21 CFR 114 (Acidified Foods) regulations, rendering their products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Failure to File Scheduled Process (21 CFR 108.25(c)(2)):** The firm lacked a current scheduled process for "Pickled Sour Onions in Vinegar Brine." A previously submitted process was returned, and a revised one is needed. 2. **Failure to Adhere to Scheduled Process (21 CFR 114.80(a)(1)):** The critical factor of "Maximum Percentage of Onions in Pack Brine is (b)(4) by weight" was not monitored. 3. **Inadequate Processing and Production Records (21 CFR 114.100(b)):** Critical factors such as brine pH, walk-in cooler temperature (