FDA WARNING_LETTER - D. Brickman Inc - November 05, 2010

On October 28 to November 5, 2010, the FDA inspected D. Brickman Inc.'s seafood processing establishment in Albany, New York, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110).

The firm's tuna loins and mahi-mahi seafood products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because they were prepared, packed, or held under insanitary conditions. A significant violation was the firm's failure to conduct a hazard analysis and implement a written HACCP plan for tuna and mahi-mahi to control the food safety hazard of scombrotoxin (histamine) formation, as required by 21 CFR 123.6(a) and (b).

The FDA warned that failure to promptly correct these violations could result in further action, including product seizure and/or injunction against the firm's operation. D. Brickman Inc. was required to respond in writing within fifteen working days, outlining specific corrective actions taken since their August 18, 2010, correspondence, including documentation like HACCP and verification records. The letter also stated that