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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Niitikaya USA Inc. 12-Oct-05

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, CA 92612-2506
Telephone (949) 608-2900



WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTE
D

 

October 12, 2005

W/L 01-06

Mr. Victor K. Suda
Executive Vice President
Niitikaya USA Inc.
1801 Gage Road
Montebello, CA 90640-6505

Dear Mr. Suda:

On August 17 -23, 2005, the Food and Drug Administration (FDA) conducted an inspection of your facility located at 1801 Gage Road, Montebello, California 90640. The inspection was conducted to determine your firm's compliance with FDA's seafood processing regulations Hazard Analysis Critical Control Point (HACCP) Regulations, "Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products," Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). This inspection follows a previous inspection conducted in February 2003, which documented non-compliance with importer requirements, as well as other objectionable conditions
which were found again at this most recent inspection.

During our current inspection, the FDA investigator observed serious deviations from the Fish and Fishery Products Regulations. These deviations cause the fish products imported by your firm to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the seafood processing regulations through links in FDA's home page at www.fda.gov.

The FDA investigator provided you with a copy of the FDA 483, Inspectional Observations, which presents her evaluation of your firm's performance regarding various aspects of the HACCP requirements. The investigator also provided you with a copy of the Import Seafood HACCP report (form FDA 3502), which presents her evaluation of your firm's performance regarding various aspects of the HACCP requirements. The observations of primary concern to us are as follows:

1. Fish or fishery products were obtained from a country that lacked an active memorandum of understanding (MOU) or similar agreement with FDA, and no adequate written verification procedures were implemented to ensure that the fish or fishery products were not injurious to health or had not been processed under insanitary conditions, in accordance with 21 CFR Part 123.12(a)(2)(i). Specifically, your firm failed to have any written verification procedures for any of the fish and fishery products imported. This is a repeat violation noted in the February 2003 inspection.

2. If you do not obtain your fish or fishery products from a country that has an active memorandum of understanding (MOU) or similar agreement with the FDA that covers the your imported fish or fishery products, 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 such as a HACCP plan that includes histamine as a hazard.

3. You must have associated with your firm an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who is otherwise qualified through job experience to perform these functions, in order to comply with 21 C.F.R. 123.10. Job experience will qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. However, your firm does not have a single employee who is HACCP trained and certified. This is a repeat violation noted in the February 2003 inspection.

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 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 may include 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.

We are in receipt of the letter from [redacted], dated August 31, 2005, stating that she has been hired to assist your firm to meet compliance standards.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct these violations including an explanation of each step taken to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.

Please send your reply to:

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

If you have questions regarding any issues Officer at (949) 608-4428.

Sincerely,

/S/

Alonza E. Cruse
District Director