Inspections, Compliance, Enforcement, and Criminal Investigations
Cumberland Farms, Inc. 9/11/09
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
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
September 11, 2009
Mr. Joseph Petrowski, CEO
Cumberland Farms, Inc.
100 Crossing Boulevard
Framingham, Massachusetts 01702
Dear Mr. Petrowski:
We inspected your seafood processing facility, located on 165 Flanders Road, Westborough, MA, on June 30, 2009 and July 6, 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 refrigerated, ready to eat, modified atmosphere packaged tuna fish sandwiches 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 likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for refrigerated, ready to eat, modified atmosphere packaged tuna fish sandwiches to control the food safety hazards of pathogen and toxin formation, including the potential for Clostridium botulinum growth and toxin formation; and scombrotoxin (histamine) formation. We acknowledge receipt of your letter of response dated July 13, 2009, wherein you promised to provide a HACCP plan to the Agency. However, at this time, we have not received a copy of that plan.
2) You must maintain sanitation control records which, at a minimum, document monitoring and corrections set out in 21 CFR 123.11 (b), to comply with 21 CFR 123.11 (c). Specifically, your firm did not maintain sanitation monitoring records for the eight areas of sanitation associated with your refrigerated, ready to eat, modified atmosphere packaged tuna fish sandwiches. We acknowledge receipt of your letter of response dated July 13, 2009, wherein you promised to implement the use of sanitation records/logs and to conduct routine reviews of those records. However, at this time, we have not received confirmation of this correction.
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: Attention: Lori A. Holmquist, Compliance Officer, 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 207.622.8268 x 13.
John R. Marzilli
New England District