Village Green Foods, Inc. 8/9/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August, 9, 2010

W/L 36-10

Ms. Jennifer A. Rosoff
Co-Owner/ COO
Village Green Foods, Inc.
1732 Kaiser Ave.
Irvine, CA 92614-5706

Dear Ms. Rosoff:

We inspected your seafood processing facility, located at 1732 Kaiser Av, Irvine, CA on March 30, April 7 and April 9, 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 Corn Clam Chowder product is adulterated, in that it has been prepared, packed, or held 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.

We acknowledge the receipt of your faxed response to the FDA 483 on April 30, 2010. Your response is inadequate in that you have not provided details Of evidence of your corrective actions.

Your significant violations were as follows:

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 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 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 Com Clam Chowder which is packaged in oxygen-impermeable plastic bags does not list the food safety hazards of Clostridium botulinum and allergens.

Regarding your firm's response to the FDA submitted on April 30, 2010, you stated that the HACCP plan will be reassessed relative to the Clostridium botulinum hazard in product that is stored refrigerated in oxygen-impermeable bags by May 30th, 2010, and that appropriate changes will be made to the HACCP plan. However, your firm has not, as of this time, provided the Agency with a revised plan. Please refer to Chapters 13 and 18 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd edition (the Hazard Guide) for additional information related to the hazard of Clostridium botulinum, such as adequate cooking times and temperatures based on a validated study with a method of continuously monitoring both time and temperature during the cook cycle; as well as appropriate post processing handling practices with, for example, a continuous filing system to prevent recontamination during the filing and/or appropriate cooling to prevent recontamination; and appropriate storage conditions of the finished products, with for example, continuous monitoring and recording of the cooler temperatures on a 24 hour a day/7 day a week basis.

Your firm utilizes many allergenic ingredients which are different in each recipe, and consequently allergens should be identified as a reasonably likely hazard in your HACCP plan, with a critical control point for label reviews. Please refer to Chapter 19 of the Hazard Guide for additional information related to the hazard of allergens.

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 actions you are taking 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:

Blake Bevill
Compliance Director
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506

If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.

Sincerely,
/S/
District Director
Los Angeles District

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