Inspections, Compliance, Enforcement, and Criminal Investigations
New England Marketers, Inc. dba Yankee Specialty Foods 7/21/05
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
July 21, 2005
VIA CERITIFED MAIL
RETURN RECEIPT REQUESTED
Paul Lindquist, President
New England Marketers, Inc.
dba Yankee Specialty Foods
22 Fish Pier
Boston, Massachusetts 02210-2054
Dear Mr. Lindquist:
On May 4-23, 2005 we inspected your seafood processing facility, located in Boston, Massachusetts. We found that you have serious deviations from the seafood Hazard Analysis Critical Control Points (HACCP) regulation, Title 21 Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the 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, the ready-to-eat lobster bisques in plastic heat sealed bags are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.
The deviations that were found during the inspection were as follows:
1. 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 lobster bisque in reduced oxygen heat sealed plastic bags to control the food safety hazard of pathogens (i.e., Clostridium botulinum).
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:
• prevention of cross contamination from insanitary objects to food, food packaging material, and other contact surfaces;
• proper labeling, storage, and use of toxic compounds;
• exclusion of pests.
We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation, such as a completed HACCP plan, copies of all related monitoring records, or other useful information that would assist in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with 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