| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human Services
WARNING LETTER
NWE-12-11W
VIA UPS
OVERNIGHT DELIVERY
March 2, 2011
Mr. Donald C. Lundin
Owner
Four Sea's Inc.
8 Seafood Way, Unit 8
Boston, MA 02210
Dear Mr. Lundin:
We inspected your seafood processing facility, located at 8 Seafood Way, Unit 8, Boston, MA on November 9, 10, and 12, 2010. 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 refrigerated pasteurized crabmeat and refrigerated fresh tuna are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they 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 have a HACCP plan that at a minimum lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However your firm's "Canned Pasteurized Crabmeat" HACCP plan lists a monitoring procedure of "temperature" at the receiving and storage critical control point that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin formation.
We note that your firm receives canned pasteurized crabmeat that is in transit for extended periods (b)(4). In this situation, FDA recommends that temperatures be continuously monitored throughout the entire duration of the transit period. FDA further recommends that your firm control the food safety hazard of pathogens and toxin formation by requiring continuous temperature monitoring records as a condition of receipt to ascertain that product temperatures did not exceed 40°F during transit.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure "visual" examination of the "adequacy of cooling medium" at the "Receiving Scombrotoxin Fish" critical control point as required by your HACCP plan for "Scombrotoxin Fish" for "each lot" to control the hazard of scombrotoxin formation for fresh tuna. Your receiving records for October 4, 2010 and October 29, 2010 do not include observations of adequacy of cooling medium or temperature at the point of receipt. Further, Mr. Okren told our investigator that your firm was not monitoring cooling medium and temperature at receipt.
3. Because you chose to include corrective action plans in your HACCP plans for Canned Pasteurized Crabmeat and Scombrotoxin Fish your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However your corrective action, "hold and evaluate based Time/Temperature Exposure" and at the receiving and storage critical control points cannot be implemented with the monitoring procedures listed in your plans. Further, your corrective actions do not address the cause of the deviations when your. product is received without adequate temperature controls. Without continuous monitoring of temperature the only appropriate corrective action is to reject product. If the deviation occurs at receipt, it is also appropriate to discontinue the supplier until the problem is resolved.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. In your response to the FDA 483 dated November 11, 2010, you indicated that are using calibrated thermometers and continuous monitoring in the cooler. In your response to this Warning Letter, please document those changes as well as those indicated by this Warning Letter with a revised HACCP plan, monitoring records and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lori A. Holmquist, Compliance Officer, U.S. Food and Drug Administration, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8266 x 13.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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