FDA WARNING_LETTER - Snokist Growers - June 02, 2011

The FDA inspected a food processing facility in Yakima, Washington, from May 3 to June 2, 2011, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Improper Reprocessing of Adulterated Food (21 CFR 110.80(b)(9)):** The firm reprocessed moldy applesauce without an effective method against all toxic metabolites (mycotoxins) and without re-examining the food to ensure it was no longer adulterated. Eight instances of reprocessing moldy organic apple puree and applesauce were cited from January to December 2010. The firm's revised Rework Policy only addresses patulin testing, not other preformed toxic metabolites. 2. **Contamination Prevention Failures (21 CFR 110.80 & 110.80(b)(13)):** * Can seam overlap measurements for #10 applesauce cans did not meet manufacturer specifications, with no documented corrective actions. * Numerous leaking and corroded cans of various products (plums, diced pears, unsweetened applesauce