Deshaies' Associates, Inc., d/b/a Deshaies' Lobster Salad – FDA Warning Letter, May 4, 2011

On August 2, 2011, the FDA issued a Warning Letter to Deshaies' Associates, Inc. dba Deshaies' Lobster Salad following an inspection from April 5 to May 4, 2011. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The firm's Seafood Stuffing and Seafood Salad products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Additionally, Processed Seafood Lobster Salad was adulterated under Section 402(c) for containing an unsafe color additive. Several products, including Deluxe (100%) Lobster Salad, Processed Seafood Lobster Salad, Seafood Stuffing, and Mr. Lobster® Brand Real Lobster Salad, were misbranded under Section 403 of the Act.

Key violations included: - **HACCP Deficiencies:** Failure to have a HACCP plan for Seafood Stuffing to control pathogens and allergens; inadequate HACCP plan for Seafood Salad lacking critical control points for pathogen growth (Clostridium botulinum) during receipt and finished product storage, and for undeclared allergens in finished product labeling; insufficient monitoring frequency for critical control points; and inappropriate