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Fusipim Sdn. Bhd. MARCS-CMS 485814 —

Fusipim Sdn. Bhd.

United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 


February 5, 2016
Mr. Ben Eng
Executive Director
Fusipim Sdn. Bhd.
Lot 9224, Batu 4 1/2, Panchang Bedena
Sungai Besar, Selangor 45300
Reference No. # 485814
Dear Mr. Eng:
The Food and Drug Administration inspected the importer DZH Import & Export Inc., located at 1300 Metropolitan Avenue, Brooklyn, New York, U.S.A. on August 17-18, 2015. During that inspection, we collected a copy of your firm’s Hazard Analysis and Critical Control Points (HACCP) plan for the fish and fishery products your firm manufactures, specifically a HACCP plan for your “cooking line products,” dated January 2, 2015, along with a process flow chart for seafood combo.
Our review of that HACCP plan (copy attached) and associated documentation revealed serious deviations from the requirements of the seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).
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 “cooking line products” 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. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
  1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (c)(1). A “food safety hazard” is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for your “cooking line products,” dated January 2, 2015, collected during an importer inspection of DZH Import & Export Inc., located in Brooklyn, NY U.S.A., does not list the following food safety hazards:
i.    You do not list the food safety hazard of Clostridium botulinum toxin formation. Our investigator collected a photograph of your Seafood Steamboat Combo product that appears to be packaged in heat-sealed plastic bags. The food safety hazard of Clostridium botulinum growth and toxin formation is associated with packaged products which may create an anaerobic environment in which Clostridium botulinum can proliferate and produce toxin.
ii.    You do not list the food safety hazard of undeclared allergens. The label for your Seafood Steamboat Combo appears to include allergenic ingredients, such as soy, egg, etc.
  1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “cooking line products,” dated January 2, 2015, collected during an importer inspection of DZH Import & Export Inc., located in Brooklyn, NY U.S.A., list monitoring procedures and a frequency at the “(b)(4)” critical control point that is not adequate to control microbial survival. Specifically, your monitoring procedure states that you (b)(4); and (b)(4). For monitoring boiling temperature, FDA recommends that you continuously monitor the boiling temperature using a continuous temperature-recording device to measure the coldest temperature of the cooking equipment, with a visual check of the recorded data at least once per day. For monitoring the conveyor speed, FDA recommends you use a stopwatch or tachometer to monitor the speed of the belt drive wheel.
  1. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b).   However, your corrective action plan for “cooking line products” at the “(b)(4)” critical control point to control microbial survival is not appropriate. Specifically, your corrective action does not ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. Furthermore, in addition to adjusting the “temperature & speed to the correct range,” FDA recommends that you:
a.    Recook the product; or
b.    Chill and hold the product for an evaluation of the adequacy of the cooking process. If the product is found to have not received an adequate process, it should be destroyed, diverted to a non-food use, or recooked; or
c.    Divert the product to a use in which the critical limit is not applicable (e.g., divert improperly cooked or pasteurized shrimp to a shrimp canning operation); or
d.    Destroy the product.
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 and all applicable regulations, including the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
  • Your HACCP plan should identify what products are covered under the “HACCP Plan Summary of Cooking Line Products.”
  • Your process flow chart for seafood combo indicates you are (b)(4). We request that you provide a description of the cooling process, including the amount of time the product(s) are cooled before placing into the freezer, whether the products are significantly handled after frying and prior to freezing, and whether the cooked product comes in direct contact with any equipment after frying and prior to freezing.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
You should respond in writing within (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. 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 (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html
Please send your reply to Food and Drug Administration, Attention: Sheena Crutchfield, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Crutchfield via email at sheena.crutchfield@fda.hhs.gov.
William A. Correll
Office of Compliance
Center for Food Safety
       and Applied Nutrition

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