G and G Peppers, LLC – FDA Warning Letter, Aug 29, 2013

The FDA inspected G and G Peppers' food processing facility in Gaston, IN, from August 20-29, 2013, and found significant deviations from Acidified Food regulations (21 CFR Part 108 and Part 114). These conditions render the firm's acidified food products adulterated under Section 402(a)(4) of the FD&C Act.

Key violations include: 1. **Failure to File Scheduled Processes:** G and G Peppers failed to file scheduled processes with the FDA for jalapeno, banana, serrano, cherry, and habanero peppers, as required by 21 CFR 108.25(c)(2). Previous attempts in 2004 for jalapeno peppers were returned and need resubmission. The processes must be established by a qualified person (21 CFR 114.83) and reflect actual operations, including rinse methods and container sizes. 2. **Inadequate Container Examination:** The firm failed to examine containers frequently enough to prevent leakage or contamination (21 CFR 114.80(a)(4)). Investigators observed white mold-like substances on finished jalapeno, cherry, and mild banana peppers and their containers. The firm's proposed corrective action of a pre-shipment SOP review for every container is deemed inadequate, as container integrity is crucial to prevent spoilage organisms and potential *Cl