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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

H.J. Heinz Company 03-Apr-03

Department of Health and Human Services' logo

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-12-03W
VIA FEDERAL EXPRESS

April 3, 2003

William R. Johnson
Chairman, President and CEO
H.J. Heinz Company
World Headquarters
600 Grant Street
Pittsburgh, PA

Dear Mr. Johnson:

We inspected one of your seafood processing facilities, Ethnic Gourmet Foods, Inc., located at 190 Fountain Street, Framingham, MA on February 11 through 13, 20, 2003. We found that you have a serious deviation from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, 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 your shrimp fried rice product is adulterated, in that the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find this Act and the seafood HACCP regulations through links in FDA’s home page at www.fda.gov.

The deviation was as follows:

You must have a HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for shrimp fried rice to control the food safety hazard of food additives. We may take further action if you do not promptly correct these above violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

Please 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 deviations. You should include in your response documentation such as your HACCP plan, or other useful information that would assist us 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 deficiencies.

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, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (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.

You may direct your reply to Karen N. Archdeacon, Compliance Officer, at the address noted above. If you have any questions concerning this matter, please contact Ms. Archdeacon at (781) 596-7707.

Sincerely,

/s/

Gail T. Costello

District Director

New England District Office