FDA WARNING_LETTER - Winter Gardens Quality Foods, Inc. - June 13, 2012

On September 13, 2012, the FDA issued a Warning Letter to Winter Gardens Quality Foods, Inc. following an inspection from June 6-13, 2012, at their New Oxford, PA facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The refrigerated reduced oxygen packaged (ROP) seafood soups were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Specific violations for ROP seafood soups included: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan lacked a critical control point for seal integrity testing to control post-pasteurization contamination. The firm's stated manual checks lacked documentation. 2. **Missing Critical Limits (21 CFR 123.6(c)(3)):** The "Chill-4B" critical control point lacked critical limits for residual chlorine in cooling water to control pathogenic bacteria. 3. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4)):** Monitoring at the "Cook CCP-1B" critical control point was inadequate to control pathogenic