Inspections, Compliance, Enforcement, and Criminal Investigations
Chun Cheng USA Inc. 16-Nov-05
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
November 16, 2005
Mr. Troy Yu, Senior Manager
Chun Cheng USA Inc.
Irvine, CA 92620-5734
Dear Mr. Yu:
The Food & Drug Administration (FDA) concluded an inspection on June 22, 2005 of your seafood importer establishment located at 167 Huntington, Irvine, CA 92620-5734. The inspection was conducted to determine your firm's compliance with FDA's seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21 of the Code of Federal Regulations, Part 123 (21 CFR 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, 21 CFR 123.12, "Special Requirements for Imported Products." In accordance with 21 CFR 123.12(d), failure of an importer of fish or fishery products to 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). 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 . Your response dated August 23, 2005 has addressed five observations ; however, there are two significant concerns that have not been resolved.
The significant violations that remain unresolved are as follows :
1. 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 adequate affirmative step for certain products manufactured by one or more of the foreign processors selected for review during the inspection. The following deficiencies were noted for particular products and firms :
a. Acceptable affirmative steps include maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of 21 CFR Part 123 (See 21 CFR 123.12(a)(2)(ii)(D)). However, no written letter of guarantee was included for frozen Mahi Mahi processed by [redacted] in In addition, the HACCP plan submitted was not identifiable as being specific to the purported processing site, i.e. no location was listed on the plan as required by 21 CFR 123.9(a)(1).
b. Acceptable affirmative steps include obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of 21 CFR 123 (See 21 CFR 123.12(a)(2)(ii)(B)). However, there was not an adequate certificate for frozen Mahi Mahi, frozen tuna and frozen albacore ....... processed by [redacted] in [redacted]. The third party certificate supplied for this processor does not certify that the imported products were processed in accordance with the requirements of 21 CFR 123.
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 you operation 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. For instance, we may take further action to refuse admission of your imported seafood products under section 801(a) of the Act, including placing them on "detention without physical examination," seize your product(s), and/or enjoin your firm from further violating the Act.
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
Los Angeles District
222 West 6th Street, Suite 700
San Pedro, CA 90731
Mr. Troy Yu, Senior Manager
If you have questions regarding the implementation of the Seafood HACCP Regulation, 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