FDA WARNING_LETTER - Dale's LLC - November 29, 2011

On February 22, 2012, the FDA issued a Warning Letter to Dale's LLC following an inspection of their alligator processing facility in Brighton, Colorado, conducted on November 22-23, 29, 2011. The inspection revealed violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110).

The primary violation cited was the firm's failure to have and implement a written HACCP plan for canned alligator, specifically to control food safety hazards such as pathogen growth and major food allergens at the labeling step, as required by 21 CFR 123.6(a) and (b). This renders the canned alligator adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §342(a)), as it was prepared, packed, or held under insanitary conditions.

The FDA reviewed the firm's December 21, 2011, response but found it inadequate without the HACCP plan and supporting documentation. Dale's LLC was instructed to respond in writing within fifteen working days, outlining specific corrective actions, including HACCP plans and monitoring records. Failure to promptly correct these violations could result in further action, including product