Ray's Seafood Market, Inc. 12/13/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 596-7896

WARNING LETTER
NWE-05-11W

VIA United Parcel Post

December 13, 2010

Hazel Dunkling, President
Ray's Seafood Market, Inc.
74 North Street
Burlington, Vermont 05401

Dear Ms Dunkling:

We inspected your seafood processing facility, located at 7 Pinecrest Drive, Essex Junction, Vermont on August 26, 2010. 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 smoked salmon, refrigerated vacuum packaged smoked whitefish and refrigerated pasteurized crabmeat 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, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are seafood 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 reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have HACCP plans for refrigerated vacuum packaged smoked salmon, refrigerated vacuum packaged smoked whitefish and refrigerated pasteurized crabmeat to control the food safety hazard of Clostridium botulinum and toxin formation.

Please be advised that in accordance with 21 CFR 123.6(b)(2) your firm may group kinds of fish and fishery products together, or group kinds of production methods together if the food safety hazards, critical control points, critical limits and procedures identified are identical.

2. You must maintain sanitation control records which, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c). However, your firm did not maintained sanitation monitoring records since 2005 for:

a. Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;

b. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;

c. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;

d. Maintenance of hand washing, hand sanitizing, and toilet facilities;

e. Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological compounds;

f. Proper labeling, storage, and use of toxic compounds;

g. Control of employee health conditions that could result in the microbiological contamination of food, food packaging material, and food contact surfaces; and

h. Exclusion of Pests from the food plant.

Please note that any seafood products you hold for distribution you must have a hazard analysis conducted to determine whether there are food safety hazards that are reasonably likely to occur, if necessary, have and implement a written HACCP plan for those fishery products to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(s) and (b).
 

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 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: Bruce R. Ota, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.

Sincerely,

/S/
Mutahar S. Shamsi
District Director
New England District

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