Inspections, Compliance, Enforcement, and Criminal Investigations
Fukumaru Seafood Company 22-Dec-05
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
December 22, 2005
Shun C. Wang, Owner
Robert C. Wang, Acting Supervisor
Fukumaru Seafood Company
556-558 Towne Ave.
Los Angeles, CA 90013
Dear Ms. Shun C. Wang and Mr. Robert C. Wang:
The Food and Drug Administration (FDA) concluded an inspection on September 8, 2005, of your facility located at 556 Towne Ave., Los Angeles, CA 90013-2127. The inspection was conducted to determine your firm's compliance with FDA's seafood HACCP regulations, pursuant to Title 21 of the Code of Federal Regulations, Part 123 (21 CFR Part 123).
During our inspection, the FDA investigator observed serious deviations in your seafood HACCP program, including failure to comply with the importer verification requirements listed in the seafood HACCP regulation, 21CFR123.12, "Special Requirements for Imported Products." The FDA investigator also provided you with a copy of the FDA 483, Inspectional Observations, which presents an evaluation of your firm's performance regarding various aspects of the HACCP requirements.
The observations of concern to us are as follows:
I. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21CFR123.12(a)(2)(i). However, your firm does not have a product specification for Fresh Tuna imported from [redacted]
2. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for Fresh Tuna manufactured by [redacted] in [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 Federal Food, Drug, and Cosmetic Act and all requirements of the federal regulations.
You should take prompt measures to correct these 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 products without examination. Under such conditions, FDA will not issue any Certificates for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter of specific steps you have taken to correct these 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 corrections cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your written reply should be directed to:
U.S. Food & Drug Administration
Attn: J. Lawrence Stevens
Director, Import Operations Branch
222 West 6th Street, Suite 700
San Pedro, CA 90731
If you have questions regarding the implementation of the seafood HACCP regulations, you may contact Ruth P. Dixon, Compliance Officer, at (310) 971-2299 for answers and/or direction towards guidance and sources of training in achieving compliance.
We look forward to working with you to achieve a successful HACCP program.
Alonza E. Cruse