Yu I Hsiang U.S.A. corp 01-Dec-05

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 1, 2005

W/L 10-06

Mr. Chiang, President
Yu I Hsiang U.S.A.Corp.
DBA Fortuna Sea Products, Inc.
1600 Potrero Grande Drive, Suite 7
Rosemead, CA 91770-4167

Dear Mr. Chiang:

We inspected your seafood importer establishment located at 1600 Potrero Grande Drive, Suite 7, Rosemead, CA 91770-4167 on September 8 and 9, 2005. The inspection was conducted to determine your firm's compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, 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, 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). Accordingly, your fish and fishery products 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 Fisheries Products Hazards & Controls Guidance through links in FDA's homepage at www.fda.gov.

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 significant violations were 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). The following deficiencies were noted for the specific product and firm:

a. Your firm performed an Mussels manufactured by [redacted] that was not adequate. Specifically, your firm chose to maintain on file a copy, in English, of the foreign processor's HACCP plan that the imported fish and fishery products are processed in accordance with the requirements of Part 123, but your firm does not have a written guarantee from the foreign processor as required by 21 CFR 123 .12(a)(2)(ii)(D).

b. Your firm did not perform an affirmative step for Frozen Green Mussels manufactured by [redacted] in [redacted]

In addition, FDA notes that Entry [redacted] consisting of Frozen Cooked Clam Meat manufactured by [redacted] in [redacted] was sampled by FDA on July 6, 2005. This entry was found to be adulterated with Salmonella, a poisonous and deleterious substance which may render it injurious to health, pursuant to section 402(a)(1) of the Act, 21 U.S.C. § 342(a)(1). FDA issued a written notice of FDA Action, dated August 1, 2005, designating that the entire shipment be detained. On September 26, 2005 an FDA investigator discovered that of the [redacted] cartons of Frozen Cooked Clam Meat [redacted]cartons were distributed. On the same day your firm initiated a voluntary recall. As the importer of record, it is your responsibility to ensure that imported products meet all requirements of the Act and the regulations promulgated thereunder. Please note that the introduction or delivery for introduction into interstate commerce, or the receipt in interstate commerce and delivery or proffered delivery thereof, of any food that is adulterated or misbranded is a violation of section 301 of the Act.

According to an affidavit signed on November 29, 2005 you intend to export [redacted] cartons. This is not an adequate response since the entry was not held intact and was distributed in interstate commerce.

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 operate in compliance with the Act and all requirements of the federal regulations. You should take prompt measures to correct these violations. Failure to promptly correct the violations 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 from your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations. You should include in your response documentation such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, or other useful information that would assist us in evaluating your corrections. In this case, your response should also include the results of the voluntary recall. If you cannot complete all corrections before you respond, you should explain the reason for your delay and the time frame within which the corrections will be completed.

Your written reply should be directed to:

U.S. Food and Drug Administration
Attention: J. Lawrence Stevens,
Director, Import Operations Branch
222 West 6th Street, Suite 700
San Pedro, CA 90731

If you have questions regarding any issues in this letter, 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.

Sincerely,

/S/

Alonza E. Cruse
District Director