Inspections, Compliance, Enforcement, and Criminal Investigations
Ray/Col Inc. 02-Oct-06
Department of Health and Human Services
Public Health Service
New England District
RETURN RECEIPT REQUESTED
October 2, 2006
Donald Rondeau, Vice President
dba Masse's Seafood
1329 Memorial Drive
Chicopee, MA 01020
Dear Mr. Rondeau:
We inspected your seafood processing facility, located at 85 Newmarket Square, Boston, Massachusetts on July 10 to 14, August 4, 22, and 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 refrigerated vacuum packaged smoked salmon, refrigerated vacuum packaged raw fish and refrigerated pasteurized crabmeat 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 are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have a HACCP plan for the receipt and storage of refrigerated vacuum packaged smoked salmon [ready to eat], refrigerated vacuum packaged raw fish and refrigerated pasteurized crab meat to control the food safety hazard of pathogen growth and toxin formation (i .e., Clostridium botulinum). Please be further advised that under 123 .6(b) firms may choose to group kinds/types of fish and fishery products together if food safety hazards, critical control points, critical limits and procedures are identical for all the products to be grouped. Consequently, you may group your ready to eat smoked fish products, ready to eat pasteurized crab meat as well as any additional similar-products that pose a hazard for pathogen growth and toxin formation together under one plan: For additional information on control of pathogen growth and toxin formation, please refer to the Fish and Fisheries Products Hazards and Controls Guidance 3rd Edition (the Guide), particularly those chapters covering receipt and storage of these types of products to control pathogens, especially when these products are not held on ice and when refrigerated transit and refrigerated storage are for extended periods of time (i.e., greater than four hours).
For additional information on the hazard of Clostridium botulinum, especially for raw vacuum packaged products where temperatures need to be maintained at 38° F because there is no processing step that adds a secondary barrier to control Clostridium botulinum growth and toxin formation, please refer to Chapter 13 of the Guide.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm's HACCP plan for histamine species lists monitoring frequencies at the "Receiving" and "Refrigerated Storage" critical control points that are not adequate to control "histamine". Intermittent checks of the ambient temperatures are not adequate for extended refrigerated hold times (i .e., transit times greater than 4 hours or refrigerated storage) because they do not ensure that proper ambient temperatures were maintained between temperature checks. We recommend that in order to ensure maintenance of proper ambient temperatures, processors adopt methods that provide a continuous recording of the ambient temperatures at receiving for products that are in transit for extended time periods and during refrigerated storage. When checking for the presence of ice, rather than ambient temperature your monitoring procedure should include Ray/Col, Inc. randomly checking a representative number of containers to ensure the presence of an adequate amount of ice.
3. 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 plans at receiving and storage for your histamine species are not adequate because they do not list correcting the cause of the critical limit deviation (e.g., discontinuing use of the supplier or repairing your storage cooler).
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: Bruce R. Ota, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.
Gail T. Costello
New England District