Above Sea Level – FDA Warning Letter, Jun 17, 2010

On June 16-17, 2010, the FDA inspected Above Sea Level, a seafood processing facility, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's vacuum-packaged and pasteurized canned crab meat, fresh yellowtail, and ono (wahoo) fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. Failure to have a HACCP plan for refrigerated vacuum-packaged and pasteurized canned crab meat to control pathogen growth and toxin formation from *Clostridium botulinum*, as required by 21 CFR 123.6(a) and (b). 2. Failure to implement monitoring procedures and frequency as listed in the HACCP plan for scombrotoxin (histamine) forming fish at the receiving critical control point (21 CFR 123.6(b) and (c)(4)). Specifically, receiving records showed inadequate monitoring of ice and internal temperature, and a lack of documentation for quantities received. Additionally, yellowtail, ono (wahoo), and escolar, which are histamine-forming fish, were not included