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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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New England Lobster Company Inc. 14-Nov-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


San Francisco District
1431 Harbor Bay Parkway
Alameda. GA 94502-7070
Telephone: 510/337-6700




Our Reference: FEI 3001593402

November 14, 2006

Mark M. Worrall, President
New England Lobster Company, Inc .
170 Mitchell Avenue
South San Francisco, California 94080


Dear Mr. Worrall:

We inspected your seafood processing facility, located at 170 Mitchell Avenue, South San Francisco, California on August 2, 3, 4, 7, 10 and 11, 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, cooked ready-to-eat lobster meat and refrigerated, whole cooked ready-to-eat crab products 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 were as follows:

1) You must conduct 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for "COOKED CRAB & LOBSTERS" does not list:

The food safety hazard of Clostridium botulinum toxin formation in refrigerated, vacuum packaged cooked ready-to-eat lobster meat. To control the C. botulinum toxin formation hazard, FDA recommends that, in addition to refrigeration, a second barrier be utilized in refrigerated, vacuum packaged seafood product. Alternatively, if the sole barrier to toxin formation by C. botulinum type E and nonproteolytic types B and F during finished product storage and distribution is refrigeration, FDA recommends the use of time temperature integrators on each consumer package. Refer to FDA's Fish & Fisheries Products Hazards & Controls Guidance: Third Edition, page 168; for further explanation.

  • The food safety hazard of Listeria monocytogenes during the cook step of your product.

The appropriate critical limits, monitoring procedures, corrective action, recordkeeping, and verification should be established accordingly.

2) You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and exclusion of pests from the food plant required for the processing of "COOKED CRAB & LOBSTERS."

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) or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days of 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply. to the U.S. Food and Drug Administration, Attention: Ms. Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms.Figueroa at (510) 337-6795.



Joseph P. Iser, MD, DrPH, MSc
Acting District Director
San Francisco District