Silva Foods of Kansas City, Inc. – FDA Warning Letter, May 29, 2012

On May 22-29, 2012, an FDA inspection of Silva Foods of Kansas City, Inc. revealed significant deviations from Acidified Food regulations (21 CFR Part 108 and Part 114) and Current Good Manufacturing Practice (21 CFR Part 110). These violations caused their acidified food products, including various salsas, to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to register as an acidified foods manufacturer (21 CFR 108.25(c)(1)). 2. Failure to file scheduled processes for acidified products (21 CFR 108.25(c)(2)). 3. Failure to establish scheduled processes by a qualified person (21 CFR 114.83). 4. Failure to monitor final equilibrium pH values to ensure they are not higher than 4.6 (21 CFR 114.80(a)(2)). 5. Failure to mark containers with identifying codes (21 CFR 114.80(b)). 6. Failure to examine containers frequently enough to ensure protection from leakage and contamination (21 CFR 114.80(a)(4)). 7. Failure to adequately clean and sanitize food contact surfaces