G.D. Mathews and Sons Corporation dba Mathews Salad House Food Products 04-Dec-07

WARNING LETTER

NWE-04-08W

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 4, 2007

David M. Matteosian, President and Owner
G.D. Mathews and Sons Corporation
dba Mathews Salad House Food Products
521 Medford Street
Charlestown, Massachusetts 02129

Dear Mr. Matteosian:

We inspected your seafood processing facility, located at Charlestown, Massachusetts on October 17, 2007 and November 28th 2007. On both inspection dates we found that you have serious repeat 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 seafood salad is adulterated, in that it has been prepared, packed, or hold under insanitary conditions whereby it 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 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 seafood salad to control the food safety hazard of pathogens.

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 any of the eight areas of sanitation that may apply to your firms operations:

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

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

3. 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 products to cooked products;

4. Maintenance of hand washing, hand sanitizing, and toilet facilities.

5. 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 contaminants;

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

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

8. Exclusion of pests from the food plant.

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 your HACCP plan, and 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: Chris vanTwuyver, Acting Compliance Officer, US Food and Drug Administration, One Montvale Avenue. Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. vanTwuyver at 781-596-7754.

Sincerely,

/S/

Mutahar S. Shamsi
Acting District Director
New England District