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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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P.&O. Cold Logistics 26-May-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, Texas 75204-3145


May 26, 2005

05-DAL-WL-16

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Humphrey Nolan
Chief Executive Officer
P.& O. Cold Logistics
19840 Rancho Way
Dominguez Hills, California 90221

Dear Mr. Nolan:

We inspected your firm; P.& O. Cold Logistics, located at 11850 Center Road, San Antonio, Texas on March 8-10, 2005. Our inspection found that your firm has serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 21 CFR Part 123 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). Your firm is a warehouse, which is a "processor" within the meaning of the Seafood HACCP Regulations, 21 CFR 123.3(I). See Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 60 Fed. Reg. 65;096 65,114 (December 18, 1995); see also 21 CFR 123.3(k)(1) (defining "processing" to include .the "storing" of fish or fishery products). Accordingly, your pasteurized cooked crabmeat is adulterated, in that it 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 the Act and the Seafood HACCP Regulations through links in FDA's home page at http://www.fda.gov.

The deviations that were found during the inspection were as follows:

1. Pursuant to 21 CFR 123.6(a), your firm is required to conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify the preventive measures that your firm will apply to control those hazards. Also, pursuant to 21 CFR 123.6(b), your firm must have and implement a HAACP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur.

Your firm, however, does not have a HACCP plan for pasteurized cooked crabmeat to control the food safety hazards of pathogen growth and toxin formation.

We may take further action if you do not promptly correct this violation. For instance, we may initiate regulatory action without further informal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.

Please respond in writing within 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, copies of all temperature monitoring records, and corrective actions 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 deviations.

This letter may not list all of 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 Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (214) 253-5312.

Sincerely,

/S/

Michael A. Chappel
Dallas District Director