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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Prime Deli Corporation 01-Nov-05

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

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, TX 75204-3145



November 1, 2005

2005-DAL-WL-5

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Hiroshi Nakamura, President/CEO
Prime Deli Corporation
1301A Ridgeview, Suite 200
Lewisville, TX 75057

Dear Mr. Nakamura:

We inspected your firm, Prime Deli Corporation, located at 1301A Ridgeview, Suite 200 Lewisville, Texas, on July 12-19, 2005, as a follow-up to FDA's previous inspection on April 27-28 through May 2-3, 10, 2005. The inspection revealed a deviation from the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110), in the production of your sandwich and deli food products. This objectionable condition causes your products to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic (the Act), 21 U.S.C. 342(a)(4). You may find the Act and the CGMP regulation through links in FDA's home page at www.fda.gov.

FDA found that your firm failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food [21 CFR 110.35(d)]. Specifically, on July 15, 2005, prior to production start-up and after your QA supervisor walk through, FDA observed equipment including meat slicers #1 and #2 to have an accumulation of residual particles or debris. The residues were observed on food contact surfaces which are in direct contact with the metal blades used to slice ready-to-eat meats in your sandwich operation. This violation was also documented during FDA's previous inspection of your facility which ended May 10, 2005.

We may pursue further action if you do not correct this violation, or further violations of the Act and all the applicable regulations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

We recognize that your firm conducted a voluntary recall of various sandwich products manufactured between May 2-7, 2005, after two finished product samples of your Turkey, Ham and Swiss Pita product, were analyzed by FDA and found to be contaminated with Listeria monocytogenes, a pathogenic microorganism. The Turkey, Ham and Swiss Pita products were adulterated within the meaning of Section 402(a)(1) of the Act, 21 U.S.C. 342(a)(1), in that they contained a poisonous or deleterious substance, namely Listeria monocytogenes, that may have rendered the food injurious to health. In addition, your sandwiches were also adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), in that they had been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. FDA found Listeria monocytogenes in an in-line turkey sample and in numerous environmental swabs (including meat slicers #1 and #2) in your facility.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your manufacturing plant operates in compliance with the Act and the CGMP regulation for foods (21 CFR Part 110). We acknowledge receipt of a letter from your QA Manager Mr. Marcos R. Malay, dated August 3, 2005, which outlines your firm's proposed corrections to conditions noted in the Form FDA-483 that was issued, to you on July 19, 2005. FDA will verify the adequacy of these and any other corrections, during our next inspection of your facility. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (214) 253-5220.

Sincerely,

/S/

Michael A. Chappell
Dallas District Office