FDA WARNING_LETTER - Village Cannery Of Vermont, Inc. - August 04, 2009

The FDA conducted two inspections of Village Cannery of Vermont, Inc.'s applesauce manufacturing facility from May 26 to June 4, 2009, and July 20 to August 4, 2009. The inspections revealed that the company manufactured and offered for sale adulterated applesauce products.

FDA analysis of applesauce samples showed patulin levels of 250.7 ppb (Sample #493559) and 163.6 ppb (Sample #557707). These levels indicate the products are adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)], as they contain a poisonous substance that may render them injurious to health.

The inspections also found serious deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), leading to adulteration under Section 402(a)(4) of the Act [21 USC 342(a)(4)]. Specific violations include: 1. **Inadequate raw material inspection and segregation (21 CFR 110.80(a)(1)):** The firm's culling and rinsing practices were insufficient to remove visibly moldy, rotten, or damaged fruit. 2. **