|Company:||LaBore Seafood Ltd.|
|Subject:||CGMP for Foods/Seafood HACCP|
|Issuer:||New England District Office|
|Issued:||Oct. 23, 2006||Closed:||
Department of Health and Human Services
Public Health Service
New England District
VIA FEDERAL EXPRESS
October 23, 2006
Wayne LaBore Jr., Secretary
LaBore Seafood Ltd.
43 Celestial Drive.
Narragansett, Rhode Island 02282-1150
Dear Mr. LaBore:
We inspected your seafood processing facility, located at 43 Celestial Drive, Narragansett, Rhode Island on August 30 - 31, 2006. 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 pasteurized crab and seafood salad products 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 8 Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must implement the monitoring procedures and frequencies 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 procedures and frequencies to control histamine formation listed in your HACCP plan for histamine species at:
the Receiving CCP of visual observation of "product covered in" ice for each delivery of fresh fish. Our investigator observed that ice checks of the fresh fish were not conducted upon receipt.
the Refrigerated Storage CCP of the adequacy of ice by visual checks at least twice a day. Our investigator observed that no ice checks of your fresh finfish were conducted.
2. You must have a HACCP plan that at a minimum lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as " the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard ." However, your firm's HACCP plan for pasteurized crab and seafood salad lists a critical limit at the receiving CCP that states "Proper Temperature on Receiving Temp log from shipper if transit more than four hours." This critical limit is not adequate to control pathogen growth and toxin formation. When products are in transit for extended time periods (i.e., greater than 4 hours, we recommend a method capable of continuously monitoring temperature during the entire transit period. In addition, we recommend that products be maintained at a temperature of 40°F or less. Please see the Chapter 12 of the Fish and Fisheries Products Hazards and Controls Guidance for more information.
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.
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. You should include in your response documentation such as HACCP and verification records, or 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: Anthony P. Costello, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Costello at 781-596-7716.
Gail T. Costello
New England District