FDA WARNING_LETTER - Pescaderia Atlantica, Inc. - April 07, 2008

On April 1-7, 2008, the FDA inspected Pescaderia Atlantica, Inc.'s seafood importing and distributing facility in Sabana Seca, Puerto Rico, 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). These violations render their mahi-mahi, anchovy, tuna, mackerel, shad-roe, sardine, marlin, and escolar products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific violations include: 1. Failure to implement the record-keeping system for monitoring observations at receiving and refrigerated storage critical control points to control histamine formation in scombroid species fish, as stated in their HACCP plan (21 CFR 123.6(b) and (c)(7)). The firm did not record observations of ice adequacy at receipt or during refrigerated storage. 2. Inappropriate corrective action plan for scombroid species fish at the receiving critical control point to control histamine formation (21 CFR 123.7(b)). The corrective action of "re-icing" is inadequate; it should include discontinuing the use of the supplier or carrier until transportation practices improve.

The firm had been previously advised of similar recurrent deficiencies regarding scomb