FDA WARNING_LETTER - Village Green Foods, Inc. - April 09, 2010

The FDA inspected Village Green Foods, Inc.'s seafood processing facility in Irvine, CA, on March 30, April 7, and April 9, 2010, uncovering serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's Corn Clam Chowder product was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies included the HACCP plan for Corn Clam Chowder, packaged in oxygen-impermeable bags, which failed to list Clostridium botulinum and allergens as reasonably likely food safety hazards, violating 21 CFR 123.6(a) and (c)(1). The firm's April 30, 2010, response to the FDA 483 was inadequate, lacking evidence of corrective actions. Specifically, the company had not provided a revised HACCP plan for Clostridium botulinum as promised by May 30, 2010. Furthermore, the FDA noted that allergens, due to diverse ingredients, require identification as a hazard with a critical control point for label reviews in the HACCP plan. The FDA requires a written response within fifteen working days detailing specific corrective actions and supporting documentation. Failure to comply may result in further enforcement actions, including product seizure or injunction, underscoring the firm's responsibility for full regulatory compliance.