|Company:||Pescaderia Atlantica, Inc.|
|Subject:||Seafood HACCP/CGMP for Foods/Adulterated|
|Issuer:||San Juan District Office|
|Issued:||June 27, 2008||Closed:||
Department of Health and Human Services
Public Health Service
San Juan District
June 27, 2008
Return Receipt Requested
Mr. Cristobal Jimenez
Pescaderia Atlantica, Inc.
PO Box 1033
Sabana Seca, PR 00952-1037
Dear Mr. Jimenez:
We inspected your seafood importing and distributing facility, located at Road 867, Km 1.5, Sabana Seca, Puerto Rico, on April 1 - 7, 2008. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your mahi-mahi, anchovy, tuna, mackerel, shad-roe, sardine, marlin, and escolar fish products are adulterated, in that it have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov .
Your significant violations were as follows:
1. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the receiving and refrigerated storage critical control points to control histamine formation listed in your HACCP plan for scombroid species fish. Specifically, your HACCP plan states that you will record the observations of the adequacy of ice at receipt and during refrigerated storage. However, you failed to record any of these observations even though you routinely handle scombroid species fish.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for scombroid species fish at the receiving critical control point to control histamine formation is not appropriate. Specifically, your corrective action of "re-icing," when an observation finds that your scombroid species are not adequately iced, is not adequate to ensure that the cause of the deviation is corrected. Your corrective action plan should include discontinuing the use of the supplier or carrier until evidence is obtained that transportation practices have changed.
During previous FDA inspections you had been advised of similar recurrent deficiencies of your HACCP plan to adequately control the receive, storage, and distribution of scombroid forming fish species. Further, you have promised to correct such deficiencies but have failed to fully comply with the FDA applicable requirements.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos I. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions concerning the violations noted please contact Mr. Medina at (787) 474-9539.
San Juan District