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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Western Fish Company, Inc. 11-Jan-06

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

Public Health Service
Food and Drug Administration


Los Angeles District

19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900



January 11, 2006

WL 13-06

Calogero (Lillo) Augello, President
Western Fish Company, Inc.
740 South Seaside Avenue
Terminal Island, CA 90731

Dear W. Augello:

We inspected your seafood processing facility, located at 842 Flint Avenue, Wilmington, CA on September 12-14, 2005. We also concurrently inspected your dockside unloading facility at 740 South Seaside Avenue, Terminal Island, CA during the same time period, from September 12-28, 2005. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or 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 fresh, histamine-forming fish including sardines, mackerel and [redacted] tuna 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, the seafood HACCP regulation and the Fish and Fishery Products Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.

Please be aware that the HACCP controls for processors who receive fish directly from harvest vessels differ significantly from those for secondary processors who receive fish from other processors. Your firm appears to operate as both a primary processor at your dockside unloading facility (i.e. 740 South Seaside Ave, Terminal Island, CA.), and as a secondary processor (i.e. 842 Flint Avenue, Wilmington, CA.). Since concurrent inspections were performed at both your primary processor and your secondary processing facilities, this letter will serve to advise you of deviations at each location.

Your significant violations were as follows:

1. 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 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 plan for sardines lists critical limits, "fish to be placed in refrigerated seawater at [redacted]F or less within [redacted] hours of catch" and "internal fish temp. at [redacted]F or less at time of receipt" at the "Receiving at Dock" critical control point that are not adequate to control scombrotoxin formation because they do not address all necessary critical limits to achieve a complete record of the harvest vessel practices. A list of appropriate critical limit options for use in conjunction with the control strategy of monitoring harvest vessel records can be found beginning on Page 88 of the Fish & Fishery Products Hazards & Controls Guidance, Third Edition.

2. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the "Packing at Plant" critical control point to control histamine listed in your HACCP plan for sardines (Wilmington, CA location).

3. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, at your dockside unloading facility (Terminal Island, CA), your firm's HACCP plan for Sardines dated 8-19-04 lists monitoring procedures at the "Receiving" critical control point that are not adequate to determine whether or not fish have been adequately cooled because they do not include an examination of the harvest vessel documents to show the proper chill time/temperature for uneviscerated or eviscerated fish. In addition, your monitoring procedures at the "Receiving" critical control point do not state the number of fish needed to be checked for internal temperature.

4. You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 123.6(c)(2). However, at your dockside unloading facility (Terminal Island, CA), your firm's HACCP plan for Mahi Mahi and Yellowtail Tuna [sic] does not list the critical control point of refrigerated storage for controlling the food safety hazard of histamine-formation for products stored overnight.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and the seafood HACCP regulation.

You should 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 violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). . You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Your written reply should be addressed to:

Pamela B. Schweikert, Director, Compliance Branch
U. S. Food and Drug Administration
19701 Fairchild
Irvine, California 92612-2445

If you have questions regarding any issue in this letter, please contact Robert McNab, Compliance Officer at (949) 608-4409.



Alonia E. Cruse
District Director

CC: State of California, DHS/FDB
Food and Drug Branch
P.O. Box 997413 MS-7602
Sacramento, California 95899-7413