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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Koon Cheong Lung 11/27/12

  

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

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


 

November 27, 2012
 
WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Mr. Jimmy Lau, Manager
Koon Cheong Lung
No. 176 Shiyu Road
Panyu, China
 
Re: # 379998
 
Dear Mr. Lau:
 
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at No. 176 Shiyu Road, Panyu, China on July 26-27, 2012. During that inspection, we found that you had serious violations of the Current Good Manufacturing Practice (cGMP) Regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110; and the Seafood HACCP Regulation, Title 21, CFR Part 123. At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. As of now, we have not received a response from your firm to those observations.
 
Your oyster sauce is 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), in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health and whereby it may have been contaminated with filth. 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. You may find the Act, the cGMP regulations, 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 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (b).   However, your firm does not have a HACCP plan for your ready-to-eat oyster sauce to control the food safety hazard of pathogen growth and toxin formation, including Clostridium botulinum, in your finished product.

2.  You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b) to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of the water that comes into contact with food or food contact surfaces; the cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemical; control of employee health conditions; and exclusion of pests as required for the processing of your ready-to-eat oyster sauce. During our inspection it was revealed that your firm does not have any formal monitoring or recording practices related to sanitation control.

3.  Your firm failed to take all reasonable precautions to ensure production procedures do not contribute to contamination from any source in accordance with 21 CFR 110.80. For example:

  • Raw materials used to manufacture oyster sauce were placed directly on the wet floor. Additionally, a bucket of starch was placed on an opened bag of salt. The dirty bottom of the bucket was in direct contact with the salt.
  • An employee was observed using a rubber water hose that had been placed directly on the wet floor to add water into the steam kettle. Water is one of the ingredients of the oyster sauce being manufactured. The tip of the water hose was in contact with the product inside the steam kettle.
  • An employee was observed (b)(4) used in the product with bare hands and arms. 

4.  Your plant and facilities must be constructed in such a manner that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact-surfaces or food packaging materials to comply with 21 CFR 110.20(b)(4).  Specifically, our investigator observed the following:

  • Condensate from the ceiling dripping into the open steam kettle where oyster sauce was being manufactured. 
  • Condensate dripping onto open bags of raw materials such as salt, sugar, starch mixture.
  • Water leaking from ceiling in several areas, including the back area of the raw material storage and near the entrance of the production room.

5.  Your equipment and utensils must be designed and be of such material and workmanship as to be adequately cleanable and shall be properly maintained, as required by 21 CFR 110.40(a). However, your equipment and utensils were not cleaned appropriately. Specifically, layers of grease-like substance or product residue were observed on the following equipment:

  • Rotors and outside of the steam kettles
  • Plastic bucket used to hold raw materials
  • Conveyer for glass bottles and finished products
  • Product filling heads

6.  You failed to provide, where necessary, adequate screening or other protection against pests to comply with 21 CFR 110.20(b)(7). Specifically, the window in the production room was open without a screen and the investigator observed several flying insects.

7.  Your firm failed to provide food handlers appropriate training in proper food handling techniques and food-protection principles to provide a level of competency necessary for production of clean and safe food to comply with 21 CFR 110.10(c). Specifically, you informed our investigator that your employees have not received any formal training in current good manufacturing practices.

8.  Your firm did not assign responsibility for assuring compliance with current good manufacturing practices relating to personnel to competent supervisory personnel, as required by 21 CFR 110.10(d). Specifically, your general manager informed our investigator that no one at the firm is aware of or has knowledge of current good manufacturing practices.  

9.  Your firm failed to provide safety-type lighting fixtures over exposed food to comply with 21 CFR 110.20(b)(5). Specifically, our investigator observed light fixtures in the production room above or near the open steam kettle where oyster sauce was being manufactured were not covered.

10.  Your firm’s hand-washing facilities were not adequate to comply with 21 CFR 110.37(e). Specifically, our investigator observed the following:

  • The toilet facilities did not have hand-washing soap, hot water, sanitary towel service or suitable drying devices.
  • The toilet facilities did not have a sign to instruct employees to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, after using the toilet, and when their hands may have become soiled or contaminated. These signs must be posted in the processing room and restrooms.
     
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 oyster sauce 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.
 
This letter is not intended to be an all-inclusive list of the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Good Manufacturing Practice regulation (21 CFR 110), and the Seafood HACCP Regulations (21 CFR 123). 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 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. You should consider providing your US Agent with a copy of this letter.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations and should include documentation of the corrective action you have taken. Your response should include an explanation of how you plan to prevent these violations, or similar violations from occurring again. If corrective action cannot be completed within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition
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