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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bayou City Fish Co, Inc. 28-Sep-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


September 28, 2005

2005-DAL-WL-31

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Douglas Lam, President
Bayou City Fish Co, Inc.
213 East Hamilton Street
Houston, TX 77076

Dear Mr. Lam:

We inspected your firm, Bayou City Fish Co., Inc, located at 213 East Hamilton Street, Houston, Texas on July 5-7 and 25, 2005. We have found that you have serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation 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)(4). Accordingly, your pasteurized and fresh refrigerated crabmeat; farm-raised fresh and frozen shrimp; aquaculture fish; and seafood dips/salads are adulterated, in that they have been prepared, packed; or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.

The deviations observed were as follows:

1. 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 you must have and implement 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 to control the food safety hazards of Clostridium botulinum toxin formation and pathogen growth in pasteurized crabmeat, in a hermetically sealed container, and fresh, refrigerated cooked crabmeat.

We received your July 22, 2005, response to the FDA 483, lnspectional Observations that the FDA investigators issued at the conclusion of the inspection. Your revised HACCP plans for fresh and pasteurized crabmeat appear to be adequate to address this observation.

2. You must have a HACCP plan that at a minimum lists the critical limits that must be met to comply with 21 CFR §123 .6(c)(3). A critical limit (CL) is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plans for fresh and frozen farm raised shrimp list at the receiving critical control point (CCP) the CL of annual letters of guarantee from your growers. This is not adequate to control the hazards of the use of chemicals and drugs.

The revised HACCP plans for fresh and frozen farm raised shrimp that you submitted on July 22 list at the receiving CCP the CL of receipt of lot by lot guarantees from your growers. The revised plans generally appear to be adequate; however, your CL now states that the letter should guarantee that "any FDA approved drugs used at any point in raising must have been approved by FDA," but it should be revised to state that "any drugs used at any point in raising must have been approved by FDA. . . ."

3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure listed in your HACCP plan for aquaculture fish for the receiving CCP to control chemicals/pesticides/drugs. Specifically, your firm's HACCP plan for aquaculture fish lists a CL at the CCP of receiving that requires a lot by lot certification from the supplier that any drugs used have been approved and that there has been adequate withdrawal time. However, your firm is maintaining only an annual certificate from the grower.

In addition, your firm did not follow the monitoring procedure in your HACCP plan for seafood dips and salads for temperature control during transit at the receiving CCP to control pathogen growth and toxin formation. Your firm's HACCP plan for fresh seafood dips and seafood salads lists a CL at the CCP of receiving to control the temperature during transport by verifying the "temp logger in vehicle," However, your firm is only measuring the ambient temperature of the delivery truck upon arrival.

Your July 22, 2005, response to the FDA 483 generally appears to be adequate to address the violations that FDA documented at your firm; however, you did not include any documentation showing implementation of the changes you have made to your HACCP plans, such as data logger records, temperature monitoring records, and lot by lot guarantees from growers. In addition, we note that the seafood HACCP regulation has been in effect since December 18, 1997, and we discovered during this inspection that your firm still did not have a HACCP plan to control the food safety hazards associated with pasteurized and fresh crabmeat. It is your responsibility as a processor to have and implement a HACCP plan whenever a hazard analysis of a seafood product reveals a food safety hazard that is reasonably likely to occur. We will verify al! of your corrections at a follow-up inspection of your firm.

We may take further action if these violations are not promptly corrected. 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 provide documentation of the implementation of the corrective actions described in your July 22 response.

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 Regulation and the Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and alt 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) 253-5220.

Sincerely,

/S/

Michael A. Chappell
Dallas District Director