K-Pra Foods Private Limited – FDA Warning Letter, Jun 14, 2019

The FDA inspected A V Bhat Co Building, an acidified food facility in Pune, India, on June 10, 13, and 14, 2019, and found serious deviations from Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The firm's July 8, 2019, response was deemed inadequate.

Key violations include: 1. **Failure to file scheduled processes:** The firm did not file a scheduled process for its "Chilli Pickle" product with the FDA, as required by 21 CFR 108.25(c)(2). This filing must occur within 60 days of registration and before packing a new product, including details on heat processing, pH, salt, sugar, and preservative levels. 2. **Lack of qualified personnel and training:** The firm failed to provide evidence that processes were established by a qualified person with expert knowledge in acidification and processing of acidified foods (21 CFR 114.83). Additionally, no plant personnel involved in critical operations had attended an FDA-approved school, as required by 21 CFR 114.10. The firm stated its Plant Head is qualified and they are identifying someone for training, but no evidence was provided.

These violations render the acidified food products adulterated under section 402(