Inspections, Compliance, Enforcement, and Criminal Investigations
Bo Wah Enterprises, Inc. 08-Apr-04
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 8, 2004
Our Reference: CFN 2939035
Tin Yeu Au, President
Bo Wah Enterprises, Inc.
1037 Maunakea Street
Honolulu, Hawaii 96817
Dear Mr. Au:
We inspected your seafood firm on February 3, 5, and 6, 2004 to determine your compliance with FDA's seafood processing regulations, Title 21, Code of Federal Regulations, Part 123 (Seafood Hazard Analysis and Critical Control Point (HACCP) Regulations). These regulations were issued pursuant to Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). You can find this Act and the Seafood HACCP Regulation through links in FDA's home page at http://www.fda.gov.
We found that your firm has serious HACCP deviations. These deviations caused your fish and fishery products, specifically [redacted] and [redacted] to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that the fish had been prepared, packed, or held under insanitary conditions, whereby they may have been rendered injurious to health. We listed the HACCP deficiencies on a Form FDA 483 and discussed them with Mr, Ying Wai Au, Vice President, at the conclusion of the inspection. We are enclosing a copy of the Form FDA 483 for your reference, Your serious HACCP deviations are as follows:
1. You must have product specifications that are designed to ensure that fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for any seafood products imported from and [redacted] and [redacted].
2. You must implement an affirmative step, which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for any of the seafood products imported from [redacted] and [redacted].
The above-identified deviations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and the requirements of the federal regulations.
You should take prompt measures to correct the deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, FDA may detain your imported seafood without examination.
Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific steps you have taken to correct the violations, including an explanation of each step taken to prevent their recurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If you cannot complete all the corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deficiencies.
Please send your reply to the Food and Drug Administration, Attention: Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District
Enclosure: Form FDA 483