Inspections, Compliance, Enforcement, and Criminal Investigations
B & M Fish Company, Ltd. 21-Feb-06
Department of Health and Human Services
Public Health Service
New England District
February 21, 2006
RETURN RECEIPT REQUESTED
Hugo Cruz, Owner/President
B & M Fish Company, Ltd .
312 Northern Avenue
Boston, MA 02210
Dear Mr. Hugo:
We inspected your seafood processing facility, located at 312 Northern Avenue, Boston, Massachusetts on November 15 and 16, 2005. 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 clam chowder is adulterated, in that it has 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 violation was as follows:
You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have 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 refrigerated clam chowder to control the food safety hazard of pathogens.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. §350d) and our implementing regulation 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. §331 (dd). Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge off this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration for, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to the FDA.
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. §342(a)(4)) and the seafood HAACP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. §350d) and 21 CFR Part 1, Subpart H.
You should respond within 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), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). 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, Compliance Officer, One Montvale Avenue, 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 Office