FDA WARNING_LETTER - Lsg Sky Chefs, Inc - June 29, 2010

An FDA inspection of LSG Sky Chefs, Inc. in Austin, Texas, on June 28-29, 2010, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulation (21 CFR Part 110). Consequently, the firm's crab cakes and tuna on wheat sandwiches were deemed adulterated. Key violations included the failure to conduct a proper hazard analysis and list critical control points (CCPs) in HACCP plans for crab cakes (receiving, storage) and tuna on wheat sandwiches (finished product storage) to control pathogen growth (21 CFR 123.6(a) and (c)(2)). Additionally, the HACCP plan for crab cakes listed insufficient critical limits for cooking to control pathogen survival, specifically Listeria monocytogenes, and lacked adequate monitoring procedures (21 CFR 123.6(c)(3)). The firm also failed to list allergens as a food safety hazard for crab cakes and had incomplete allergen identification for tuna on wheat sandwiches (21 CFR 123.6(a) and (c)(1)). While the firm submitted an action plan, it was deemed inadequate as it lacked copies of new, approved HACCP plans and evidence of implemented corrective actions. The FDA requires a written response within 15 working days detailing specific corrective steps and supporting documentation, warning of potential product seizure or operational injunction if violations are not promptly corrected. The firm is responsible for ensuring full compliance with all applicable regulations.