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U.S. Department of Health and Human Services

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Enforcement Actions

Li Da Seafood Trading Inc. 12/9/11

  

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

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Ave.                       
Jamaica, NY 11433

 

December 9, 2011
 
WARNING LETTER NYK-2012-06 
 
 
VIA UNITED PARCEL SERVICE
 
 
Mr. Gwoli Chen
President
Li Da Seafood Trading, Inc.
36-31 College Point Blvd.
Flushing, New York 11354
 
Dear Mr. Chen:
 
We inspected your seafood processing facility, located at 36-31 College Point Blvd., Flushing, New York on November 2 & 4, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations,  Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 C.F.R. §§ 123 & 110). In accordance with 21 § C.F.R. 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 refrigerated, ready–to-eat tuna and vacuum packaged hamachi are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You  may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov.
 
Your significant violations were 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 C.F.R. §§ 123.6(a) and (b). However, your firm does not have a HACCP plan for vacuum packaged hamachi (amberjack or yellowtail)  to control the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum growth and toxin formation.
 
2.  You must implement the recordkeeping system that you listed in your HACCP plan to comply with 21 C.F.R. §§ 123.6(b) and (c)(4). However, your firm did not record monitoring observations at the receiving and product storage Critical Control Points to control the significant hazard of histamine formation as listed in your HACCP plan for “Fresh Tuna.”  For example, your firm was processing fresh tuna during the inspection, but your firm had no monitoring records available for the receipt or storage of fresh tuna as required by your HACCP plan. Further, your HACCP plan indicates continuous recording of cooler temperature, but your cooler is not equipped with a continuous temperature data logger.
 
FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage; however, your HACCP plan and monitoring records should reflect this monitoring activity accordingly. FDA recommends that you check the adequacy of ice or cooling media at least twice per day.
 
3. You must maintain sanitation control records, that, at a minimum, document monitoring and corrections to comply with 21 C.F.R. § 123.11 (c). However, your firm did not maintain sanitation monitoring records for: the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; condition and 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 chemicals; control of employee health conditions; and exclusion of pests.
 
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 C.F.R. Part 110, to comply with 21 C.F.R. § 123.11(b). However:
 
(A.) Your firm did not adequately monitor the safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice as required by 21 C.F.R. § 123.11(b)(1) with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 C.F.R. Part 110 as evidenced by the below observations:
 
  • Your ice scoop was stored directly inside of your ice machine and fresh ice was observed to be coming into direct contact with the handle of this scoop. Ice manufactured in this machine was observed to be stored directly on various fish stored in your walk-in cooler.
  • The interior of your ice machine was observed to have a build-up of apparent black mildew on the upper interior. Ice manufactured in this machine was observed stored directly on various fish stored in your walk-in cooler.
 
(B) Your firm did not adequately monitor the conditions and cleanliness of food contact surfaces as required by 21 C.F.R. § 123.11(b)(2) with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 C.F.R. Part 110 as evidenced by the below observations:
 
  • The cutting boards in your production area were observed to have deep scours and were heavily stained with a build-up of food residue. During this inspection, fresh tuna was observed to be cut on these boards.
  • Clean knives, sharpening objects and scissors used to process your tuna were observed to be stored in a heavily stained styrofoam container.
 
(C) Your firm did not adequately monitor the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments and from raw product to cooked product as required by 21 C.F.R. § 123.11(b)(3) with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 C.F.R. Part 110 as evidenced by the below observations:
 
  • Boxes of fish were observed to be stored directly on the floor of your walk-in cooler. The walk-in cooler floor was observed to be absorbent and not easily cleanable.
 
(D) Your firm did not adequately monitor the protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contamination as required by 21 C.F.R. § 123.11(b)(5) with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 C.F.R. Part 110 as evidenced by the below observations:
 
  • The ceiling above your walk-in freezer in your warehouse area and the ceiling throughout the warehouse area was observed to be leaking water from the outside. A heavy build-up of apparent mildew was observed above your walk-in freezer and ceiling tiles were missing/damaged throughout the warehouse. Water was observed to be leaking into the walk-in freezer and accumulating frozen ice crystals throughout the freezer. Packaged food products were observed to be stored directly beneath areas of the warehouse where the ceiling is leaking and throughout the freezer.
  • Numerous light bulbs were unshielded and exposed throughout your walk-in coolers and processing area.
  • The walls in your walk-in cooler and processing area were observed to have dried food residue build-up, especially around the tuna processing tables.
 
(E) Your firm did not adequately monitor the maintenance of hand washing, hand sanitizing and toilet facilities as required by 21 C.F.R. § 123.11(b)(4) with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 C.F.R. Part 110 as evidenced by the below observations:
 
  • There was no soap or paper towels available for hand washing at the hand wash sinks located in your upstairs restroom or in your processing area.
 
(F) Your firm did not adequately monitor the exclusion of pests from the food plant as required by 21 C.F.R. § 123.11(b)(8) with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 C.F.R. Part 110 as evidenced by the below observations:
 
  • A cat was observed in the office of this facility.
  • Apparent cat pellets were observed throughout the upstairs storage area where packaging material and various food supply items are stored.
  • Several cardboard boxes containing packaging items had apparent claw marks and damage.
  • Two fly strips with numerous flies were observed hanging from the ceiling outside the doors of the processing area.
  • Both the loading dock door and the main entrance doors were observed to be open throughout the entire inspection.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
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.
 
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 C.F.R. Part 123) and the Current Good Manufacturing Practice regulation (21 C.F.R. Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

 
Please send your written reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have any questions regarding this letter, please contact Ms. Aveta at 718-662-5576.
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District