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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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West Bay Seafood Co., Inc. 28-Dec-04

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

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-70770
Telephone: 510/337-6700


VIA FEDERAL EXPRESS
Our Reference: 3003529852

December 28, 2004

Hong B. Pham, President
West Bay Seafood Co. Inc.
Pier 45, Shed B-11, Mailbox #3
San Francisco, California 94133

WARNING LETTER

Dear Mr. Pham:

On September 9, 15, 16, and 21, 2004, we inspected your seafood processing facility, located at Pier 45, Shed B-11, San Francisco, California. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR l23). 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 processed there 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 fresh scombroid fish products are adulterated, in that the products 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 were as follows:

1. You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for Fresh Scombroid Fish does not list the critical control point of processing to control the food safety hazard of histamine formation. During the inspection, FDA observed tuna product in the processing area for in excess of three hours at a temperature of 60.8°F; it seems reasonably likely that time and temperature abuse could occur at this processing step.

2. You must provide for a recordkeeping system that documents the monitoring of your critical control points with actual values and observations to comply with 21 CFR 123.6(c)(7). However, your firm did not adequately or accurately record monitoring observations, to control scombroid toxin formation, at the receiving critical control point in your Fresh Scombroid Fish HACCP plan for tuna. Specifically, on September 9, 2004, FDA observed incoming tuna to be at temperatures above 40°F. Your firm employee inaccurately filled out the Quality Control and Receiving Report for incoming tuna. For example, the "Adequate Cooling Media?" column was marked "Yes," when adequate cooling media was not present, and the "Product Exceed CCP?" column was marked "No," when, in fact, the critical control point had been exceeded.

3. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Scombroid toxin Fish Species at the receiving and storage critical control points to control histamine, formation is not adequate because it does not specify the number of fish that will be tested for histamine formation, and it does not address the cause of the deviation at the storage critical control point. FDA recommends histamine analysis of 60 fish or of the entire lot for lots smaller than 60 fish.

4. You must fully document, in records, all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of 40°F internal temperature for [redacted] tuna at the receiving critical control point to control histamine formation on September 9, 2004.

At the conclusion of the inspection, the deviations were listed on Form FDA 483 and discussed with you. A copy of this form is enclosed for your ready reference. This list is not meant to be an all-inclusive list of violations. You are responsible for ensuring that your processing facility operates in compliance with the Act, the seafood HACCP regulation, and the Current Good Manufacturing Practice regulation (21 CFR l10).

During the Inspection, FDA collected FDA Sample No. 290463, [redacted] tuna, and FDA Sample No. 290454, [redacted] tuna FDA analyses are summarized in the following table:

Sample Number

Product

Number of Sub-Samples Decomposed

Range of Histamine Values*

290463

[redacted] tuna

4 of 13

14.6 - 97.4 ppm

290464

[redacted] tuna

14 of 14

10.7 - 170 ppm

*The FDA action level for histamine in tuna is greater than or equal to 50 ppm

The products were both adulterated within the meaning of Section 402(a)(3) of the Act in that they consist in whole or in part of a decomposed substance. FDA recommends that processors of scombroid toxin-forming fish recognize that 50 ppm histamine occurs only after significant time/temperature abuses of the fish that allow for histatnine-forming bacteria to proliferate in the fish product. Those abuses should indicate to the processor that other fish in the lot may have high enough histamine, or other biogenic amine levels to render the fish scombrotoxic and cause illness in consumers, and that corrective action which may include discarding of the fish, is necessary. The abuses that resulted in the elevated histamine levels could have occurred anywhere from harvest (before it came into your control) to improperly controlled processes in your facility. We acknowledge that you voluntarily sold the remaining lots of product for non-food use. We recommend that you follow up on these issues with your suppliers, [redacted] and [redacted]

We may take further action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating. In addition, FDA may detain your imported seafood products without examination.

Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific things you are doing to correct them deviations. You should include in your response documentation 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.

Please send your reply to: Ms. Erlinda N. Figueroa, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District

Enclosure: Form FDA 483