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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fong Hsiang Enterprise Co. Pte. Ltd. 14-Nov-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
Washington, DC 20204
WARNING LETTER

Mr. Albert Lee
Managing Director
Fong Hsiang Enterprise Co. Pte. Ltd.
No. 1 Fishery Port Road
Jurong Ind. Estate
Singapore 619726

Dear Mr. Lee:

We inspected your firm, located at No.1 Fishery Port Road, Jurong Ind. Estate, Singapore, on April 18, 2001, and found that you have serious deviations from the Seafood HACCP Regulations (21 CFR Part 123). These deviations, some of which were previously brought to your attention, cause your Frozen Wahoo and Tuna to be in violation of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. You can find this Act and the seafood HACCP regulations through links in FDA?s home page at www.fda.gov.

Thank you for your prompt response of May 15, 2001 to our investigation findings. Your letter states that you are now sending samples of the tuna you receive to a laboratory to be tested for histamine content. You also state that you have included and implemented controls for the hazard of metal inclusion in your HACCP plan for Frozen Swordfish and that the sanitation deficiencies listed in the FDA 483 have been corrected.

In addition to the deficiencies noted during our inspection, we have made the following determinations during our review of the USFDA inspection report submitted by our investigation team:

The deviations were as follows:

1. You must have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). Your firm?s HACCP plans for Frozen Yellowfin Loin and Frozen Wahoo Loin do not list a critical limit for sensory evaluation at your receiving critical control point to control the food safety hazard of histamine. USFDA recommends that lots be rejected if more than 2.5% of the lot exhibits characteristics of decomposition. Your sampling plan for sensory evaluation must be representative of the lot. USFDA recommends 118 fish. Chapter 7 of the Fish & Fishery Products Hazards and Controls Guide provides an example of how this information can be included in your HACCP plan.

2. You must have a HACCP plan that lists monitoring procedures for each critical control point to comply with 21 CFR 123.6(c)(4). Your firm?s HACCP plans for Frozen Yellowfin Loin and Frozen Wahoo Loin do not list the monitoring procedures and frequencies for sampling fish for histamine testing. The plan states that you will evaluate the appearance of the fish by a "visual review" and sensory testing to determine histamine content. Visual examinations and sensory testing cannot provide consistently accurate determinations of histamine content.

Your response states that you are sending samples from each shipment of fish to a lab for histamine testing. Your corrected plan should list this as part of your monitoring procedures and include a representative sampling frequency. The new Fish and Fishery Products Hazards and Controls Guide recommend that a sampling frequency of 18 fish per lot be analyzed.

Your monitoring frequency for internal temperature lists "every fish hold". We are unsure if this means every fish in the ship hold or every hold of fish. We would appreciate your explaining this phrase.

Note: In addition to the above deviations, your corrective action of testing for histamine content in the product that does not pass your sensory evaluations would no longer be appropriate since your lots will be tested for histamine content as part of your regular monitoring procedures at your Receiving critical control point.

Please respond in writing within six weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. Please include in your response copies of your corrected HACCP plans (in English) and five days of completed monitoring records results, histamine testing results, harvest vessel records, corrective actions, or other useful information (translated to English where necessary) that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations. Failure to provide us evidence of corrections to the deviations may result in your products being placed on "Detention Without Physical Examination."

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to:

Food and Drug Administration
Attention: Brian Landesberg, Consumer Safety Officer
Office of Field Programs
Division of Enforcement and Programs, Import Branch HFS-606
200 C Street S.W.
Washington, DC 20204

If you have questions regarding any issue in this letter, please contact Mr. Landesberg at (202) 205-5247.

Sincerely,
Sonia D. Delgado for
Judith A. Gushee
Director
Division of Enforcement and Programs
Office of Field Programs
Center for Food Safety and Applied Nutrition