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WARNING LETTER

Yuet Heung Yuen Sauce Food (ZhuHai) Co., Ltd MARCS-CMS 417628 —


Recipient:
Yuet Heung Yuen Sauce Food (ZhuHai) Co., Ltd


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
 
5100 Paint Branch Parkway
College Park, MD 20740

January 15, 2014

 
 
 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Mr. Simon Liu, Owner/President
Yuet Heung Yuen Sauce Food (Zhuhai) Co., Ltd.
Rm 1509, Workingberg Commercial Building
41-47 Marble Road, North Point, Hong Kong
 
Reference No. 417628
 
Dear Mr. Liu:
 
We inspected your seafood processing facility, Yuet Heung Yuen Sauce Food (Zhuhai) Ltd., located at No 38 Sing Ping Road, Pingsha District, Zhuhai City, China on September 23-25, 2013. 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, Part 123 (21 CFR 123). At the conclusion of the inspection, FDA issued a FDA-483, Inspectional Observations, listing the observations of concern found at your firm. We acknowledge receipt of your response sent via email on October 1, 2013, that included a written description of the corrective measures your firm intends to take to correct the observations of concern, but which did not include any additional supporting documentation such as a revised HACCP plan. We have assessed the response and have continuing concerns as further described in this letter.
 
In accordance with 21 CFR 123.6(g), failure of a processor of fish and 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 oyster sauce is adulterated, in that it has been prepared, packed, or held under conditions whereby it 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 Control Guidance (the Hazard Guide) through links in FDA’s homepage 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 FDA’s website at:
 
 
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 (b)(4) that was collected during the inspection does not list the food safety hazard of undeclared allergens. (b)(4) is a major food allergen and major food allergens are a food safety hazard. FDA recommends that your firm include in your HACCP plan appropriate controls to assure that all allergenic ingredients, including the soy, are correctly declared on the finished product labels.  
 
2.    You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for (b)(4) that was collected during the inspection) does not list a critical control point for controlling the identified food hazard of “pathogen residue” following the “(b)(4)” critical control point. Specifically, this (b)(4), which is the only critical control point in your plan, is not considered adequate as the sole strategy to control pathogens in your finished product because it is conducted before the product is packaged and sealed in the final container. Our investigator observed that after cooking the product, your firm passes the product through a (b)(4), which could lead to (b)(4). FDA recommends your firm identify a critical control point in your HACCP plan to control post-cook pathogen contamination, specifically to control the pathogen hazard of Clostridium botulinum germination, growth and toxin formation in your (b)(4)Clostridium botulinum should be your target pathogen because your finished products are packaged in (b)(4).  Consequently, FDA suggests that your firm adopt one of the following strategies as part of the post-cook critical control point:
 
  • Controlling the pH of the finished product to 4.6 or less
  • Controlling the water activity of the finished product to 0.85 or less
  • Controlling the water phase salt content in the finished product to 20% or more
 
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. 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
 
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.
 
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 defined as 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.
 
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov
 
Sincerely,
 /S/
Charlotte Christin  
Acting Director
Office of Compliance
Center for Food Safety
       and Applied Nutrition

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