As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Shung Kee Food Co., Ltd.,  New York, NY

Yuk Leung Lok, President

In a March 20 warning letter, the FDA described an Oct. 21-22, 28-31, and Nov. 6 and 15, 2019, inspection at Shung Kee Food Co. Ltd., New York City. Inspectors found that the company has serious violations of the seafood Hazard Analysis and Critical Control Point.

The FDA  acknowledged receipt of their response on Dec. 4, 2019, which included corrective actions, hazard analysis, HAACP Plan, water testing, training material, and training certification. However, the FDA’s evaluation of the response revealed it was not adequate.

FDA’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations.

FDA inspection revealed the following violations:

1) The company’s revised HACCP plan dated Dec. 3, 2019, for boiled fish balls, fried fish cakes, and fried fish balls in hermetically sealed packaging lists a monitoring procedure of placing a probe thermometer into (redacted) of fish balls or cakes with a frequency of approximately every (redacted) at the “Post Cooking Process (Cooling and packing)” critical control point (CCP). During the inspection, the FDA investigator observed that internal temperature probes used to monitor product temperatures during fan and refrigeration cooling are not consistently placed in the same locations from batch to batch and are not representative of the densest, hottest locations, such as where fish cakes overlap each other on the cooling trays. Temperatures of the thickest and overlapping product areas were observed at 30° F higher than temperatures of the locations determined by employees. This procedure is inadequate because it does not ensure that in-process product internal temperatures are cooled within the critical time and temperature limits identified in the company’s HACCP plan for (redacted) products to control the food safety hazard of pathogen growth.

2) The company must implement the record-keeping system that they listed in their HACCP plan. The firm did not record monitoring observations at the “Post-Cooking Processing Cooling” critical control point to control the food safety hazard of pathogen growth listed in their HACCP plan for boiled fish balls, fried fish cakes, and fried fish balls in (redacted) plastic film. The firm did not have post-cooking process cooling monitoring records documenting times and temperatures of products that were cooled after cooking between Jan. 3 and Jan. 14, 2019. A review of the firm’s Cooking CCP monitoring records during this period revealed that your firm was manufacturing and cooking fish products during this time.

3) The company did not document that corrective action was taken when you deviated from your critical limit of “No more than (redacted) at product internal temp. below (redacted), below (redacted), below (redacted) afterward” for boiled fish balls, fried fish cakes, and fried fish balls in (redacted) plastic film at the” Post-Cooking Process Cooling” critical control point. A review of the company’s Post Cooking Process Cooling monitoring records revealed that at least one occasion products were not cooled below the listed critical limit.

4)  The firm’s “Cooking” critical control point monitoring records identified deviations from their temperature critical limit on multiple production days. They determined these deviations were the result of the improper use of (redacted) temperature recording devices by employees. The firm did not perform or document any corrective actions.

The full warning letter can be viewed here.

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