Family Loompya Corporation – FDA Warning Letter, Jan 14, 2015

On April 21, 2015, the FDA issued a Warning Letter to Family Loompya Corporation following an inspection from January 13-14, 2015, at their National City, CA seafood processing facility. The inspection revealed 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).

The firm's Vegetable and Shrimp Lumpia product was deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, LUMPIA Savory Vegetables and Shrimp in a Thin Crispy Wrapper and LUMPIA Savory Vegetables in a Thin Crispy Wrapper products were found to be misbranded under 21 U.S.C. § 343.

Key violations included: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for Vegetable and Shrimp Lumpia failed to identify undeclared shrimp, wheat, and soy allergens as food safety hazards and lacked controls for proper allergen labeling and label application. 2. **Failure to Implement Monitoring Procedures (21 CFR 123.6(b) and (c)(4)):** The firm did not follow monitoring procedures at CCP