Inspections, Compliance, Enforcement, and Criminal Investigations
Beekman Foods Inc 9/1/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District|
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
RETURN RECEIPT REQUESTED
Date: September 1, 2009
Michael J. Simeone
Beekman Foods Inc.
300 Wildwood Avenue
Woburn, MA 01801
Dear Mr. Simeone:
We inspected your seafood processing facility, located at 300 Wildwood Avenue, Woburn, MA 01801 on May 15, and 20, 2009. 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 ready-to eat seafood products such as tuna salad and imitation crabmeat are adulterated, in that they may 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 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). Specifically, your firm does not have a HACCP plan for ready-to-eat seafood products such as tuna salad and imitation crabmeat to control the food safety hazard of pathogen growth and toxin formation. FDA recommends that warehouses implement controls at receipt and storage for ready-to-eat seafood products.
2 You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11 (c). However, your firm did not maintain sanitation monitoring records for the safety of water, the condition and cleanliness of food contact surfaces, cross contamination, maintenance of hand-washing hand sanitizing and toilet facilities, protection from adulterants, labeling storage and use of toxic compounds and employee health conditions required for the processing of ready-to-eat tuna salad and imitation crabmeat.
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 a HACCP plan 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 plan 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, Compliance Officer. If you have questions regarding any issues in this letter, please contact Mr. Costello at 781 596-7716.
John R. Marzilli
New England District