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WARNING LETTER

Sen Up Huat Seafood Trading Sdn Bhd MARCS-CMS 677684 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Siew Lan Lim
Recipient Title
Managing Director
Sen Up Huat Seafood Trading Sdn Bhd

Lot 9999, Jalan Tepi Sungai
36400 Hutan Melingtang
Perak
Malaysia

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

March 6, 2024
 

WARNING LETTER
Reference #: CMS 677684

Dear Ms. Lim,

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Lot 9999, Jalan Tepi Sungai, Hutan Melingtang, Perak, Malaysia, on October 23 & 24, 2023. During the inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response, received via email on November 10, 2023, which included corrective actions and supporting documentation taken by your firm in response to the observations noted on the FDA-483. Our evaluation of the documentation provided in your response revealed that your response was not adequate, as further described in this letter.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise 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 fresh and frozen histamine forming seafood products, including but not limited to, bonito, are adulterated in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

Your significant violations are as follows:

1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for histamine forming species including frozen, raw, bonito does not list critical limits at the receiving critical control point that are adequate to control for the hazard of histamine formation after capture aboard the harvest vessel. FDA recommends controls of either harvest vessel records for each vessel lot or histamine testing with a limit of less than 50 ppm histamine as critical limits.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s), and/or enjoin your firm from further violating the Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at amy.glynn@fda.hhs.gov. Please reference CMS # 677684 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Ann Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition

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