1) Temperature monitoring of a cooling step did not take worse-case scenario for product characteristics as well as did not have an adequate frequency.
"FDA recommends when selecting samples to consider the variables that affect the rate of cooling and represent “worst case” conditions. This can include overlapped or closely placed units, the position of the units in the tray and on the (b)(4) where heat may be retained (e.g., the units in the center of the trays in the middle of the (b)(4)), and the distribution of cold air in the cooling room. In addition, your listed frequency, “at least every (b)(4),” is inadequate to show that your critical limit of “…no more than (b)(4) of those (b)(4) is above (b)(4)” is not exceeded."2) The company was missing monitoring records.
"...firm did not have post cooking process cooling monitoring records documenting times and temperatures of products that were cooled after cooking between January 3 and January 14, 2019. Review of your 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 have corrective action records for certain process deviations.
"a review of your Post Cooking Process Cooling monitoring records revealed that at least on one occasion products were not cooled below the listed critical limit......Your firm’s response dated December 4, 2019 stated that a corrective action was performed at the time of the deviation even though a record was not created."4) The firm did not take appropriate corrective action in response to certain deviations.
"...firm’s “Cooking” critical control point monitoring records identified deviations from your temperature critical limit on multiple production days. However, you determined these deviations were the result of the improper use of (b)(4) temperature recording devices by employees. You firm did not perform or document any corrective actions."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shung-kee-food-co-ltd-598630-03202020
Shung Kee Food Co., Ltd.
MARCS-CMS 598630 — March 20, 2020
Recipient:
Mr. Yuk Leung Lok
President
Shung Kee Food Co., Ltd.
85 Ludlow Street
New York, NY 10002
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
WARNING LETTER
CMS # 598630
Shung Kee Food Co., Ltd.
MARCS-CMS 598630 — March 20, 2020
Recipient:
Mr. Yuk Leung Lok
President
Shung Kee Food Co., Ltd.
85 Ludlow Street
New York, NY 10002
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
WARNING LETTER
CMS # 598630
March 20, 2020
Dear Mr. Lok:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Shung Kee Food Co., Ltd. located at 164 42nd Street, Brooklyn, NY on October 21-22, 28-31 and November 6, and 15, 2019. During that inspection, 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 (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response dated December 4, 2019, which included corrective actions, hazard analysis, HAACP Plan, water testing, training material, and training certification. However, our evaluation of your response revealed it was not adequate as further explained in this correspondence.
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 various fish ball and fish cake products 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 4th Edition Fish and Fisheries Products Hazards & 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 have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your revised HACCP plan dated December 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 (b)(4) of fish balls or cakes with a frequency of approximately every (b)(4) at the “Post Cooking Process (Cooling and packing)” critical control point (CCP). During the inspection, the 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 your HACCP plan for (b)(4) products to control the food safety hazard of pathogen growth.
We acknowledge your response dated December 4, 2019 that included the revised HACCP plan for boiled fish balls, fried fish cakes, and fried fish balls in hermetically sealed packaging. With respect to the “Post-Cooking Processing (Cooling and packing)” CCP, we note that the revised plan directs the testing of (b)(4) from the (b)(4) to monitor cooling temperatures. FDA recommends when selecting samples to consider the variables that affect the rate of cooling and represent “worst case” conditions. This can include overlapped or closely placed units, the position of the units in the tray and on the (b)(4) where heat may be retained (e.g., the units in the center of the trays in the middle of the (b)(4)), and the distribution of cold air in the cooling room. In addition, your listed frequency, “at least every (b)(4),” is inadequate to show that your critical limit of “…no more than (b)(4) of those (b)(4) is above (b)(4)” is not exceeded.
2) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your 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 your HACCP plan for boiled fish balls, fried fish cakes, and fried fish balls in (b)(4) plastic film. Specifically, your firm did not have post cooking process cooling monitoring records documenting times and temperatures of products that were cooled after cooking between January 3 and January 14, 2019. Review of your firm's Cooking CCP monitoring records during this period revealed that your firm was manufacturing and cooking fish products during this time.
We reviewed your response dated December 4, 2019 where you stated that your firm was unable to locate the lost data. Your response indicates you will implement a process to have a soft copy and printed hard copy of the raw data in order to have redundancy in the event of lost files in the future. We will verify the implementation and adequacy of these corrective actions during our next inspection.
3) You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of “No more than (b)(4) at product internal temp. below (b)(4), below (b)(4), below (b)(4) afterwards” for boiled fish balls, fried fish cakes, and fried fish balls in (b)(4) plastic film at the” Post-Cooking Process Cooling” critical control point. Specifically, a review of your Post Cooking Process Cooling monitoring records revealed that at least on one occasion products were not cooled below the listed critical limit.
Your firm’s response dated December 4, 2019 stated that a corrective action was performed at the time of the deviation even though a record was not created. Further, your response indicates that in addition to further training you are also testing a new temperature data logger in an effort to limit human error. We will verify the implementation and adequacy of these corrective actions during our next inspection.
4) You must take an appropriate corrective action when a deviation from a critical limit occurs to comply with 21 CFR 123.7(a). However, your firm’s “Cooking” critical control point monitoring records identified deviations from your temperature critical limit on multiple production days. However, you determined these deviations were the result of the improper use of (b)(4) temperature recording devices by employees. You firm did not perform or document any corrective actions.
We reviewed your response dated December 4, 2019 that stated your employee has completed a basic HACCP training course which was conducted on site. We will verify the implementation and adequacy of these corrective actions during our next inspection.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. 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., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation. 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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
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 Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
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 reinspection 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 reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). 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 send your reply to the Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, One Winner’s Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Izyk at 518-453-2314 x 1012 or by email at scott.izyk@fda.hhs.gov.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1
Dear Mr. Lok:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Shung Kee Food Co., Ltd. located at 164 42nd Street, Brooklyn, NY on October 21-22, 28-31 and November 6, and 15, 2019. During that inspection, 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 (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response dated December 4, 2019, which included corrective actions, hazard analysis, HAACP Plan, water testing, training material, and training certification. However, our evaluation of your response revealed it was not adequate as further explained in this correspondence.
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 various fish ball and fish cake products 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 4th Edition Fish and Fisheries Products Hazards & 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 have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your revised HACCP plan dated December 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 (b)(4) of fish balls or cakes with a frequency of approximately every (b)(4) at the “Post Cooking Process (Cooling and packing)” critical control point (CCP). During the inspection, the 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 your HACCP plan for (b)(4) products to control the food safety hazard of pathogen growth.
We acknowledge your response dated December 4, 2019 that included the revised HACCP plan for boiled fish balls, fried fish cakes, and fried fish balls in hermetically sealed packaging. With respect to the “Post-Cooking Processing (Cooling and packing)” CCP, we note that the revised plan directs the testing of (b)(4) from the (b)(4) to monitor cooling temperatures. FDA recommends when selecting samples to consider the variables that affect the rate of cooling and represent “worst case” conditions. This can include overlapped or closely placed units, the position of the units in the tray and on the (b)(4) where heat may be retained (e.g., the units in the center of the trays in the middle of the (b)(4)), and the distribution of cold air in the cooling room. In addition, your listed frequency, “at least every (b)(4),” is inadequate to show that your critical limit of “…no more than (b)(4) of those (b)(4) is above (b)(4)” is not exceeded.
2) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your 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 your HACCP plan for boiled fish balls, fried fish cakes, and fried fish balls in (b)(4) plastic film. Specifically, your firm did not have post cooking process cooling monitoring records documenting times and temperatures of products that were cooled after cooking between January 3 and January 14, 2019. Review of your firm's Cooking CCP monitoring records during this period revealed that your firm was manufacturing and cooking fish products during this time.
We reviewed your response dated December 4, 2019 where you stated that your firm was unable to locate the lost data. Your response indicates you will implement a process to have a soft copy and printed hard copy of the raw data in order to have redundancy in the event of lost files in the future. We will verify the implementation and adequacy of these corrective actions during our next inspection.
3) You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of “No more than (b)(4) at product internal temp. below (b)(4), below (b)(4), below (b)(4) afterwards” for boiled fish balls, fried fish cakes, and fried fish balls in (b)(4) plastic film at the” Post-Cooking Process Cooling” critical control point. Specifically, a review of your Post Cooking Process Cooling monitoring records revealed that at least on one occasion products were not cooled below the listed critical limit.
Your firm’s response dated December 4, 2019 stated that a corrective action was performed at the time of the deviation even though a record was not created. Further, your response indicates that in addition to further training you are also testing a new temperature data logger in an effort to limit human error. We will verify the implementation and adequacy of these corrective actions during our next inspection.
4) You must take an appropriate corrective action when a deviation from a critical limit occurs to comply with 21 CFR 123.7(a). However, your firm’s “Cooking” critical control point monitoring records identified deviations from your temperature critical limit on multiple production days. However, you determined these deviations were the result of the improper use of (b)(4) temperature recording devices by employees. You firm did not perform or document any corrective actions.
We reviewed your response dated December 4, 2019 that stated your employee has completed a basic HACCP training course which was conducted on site. We will verify the implementation and adequacy of these corrective actions during our next inspection.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. 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., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation. 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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
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 Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
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 reinspection 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 reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). 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 send your reply to the Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, One Winner’s Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Izyk at 518-453-2314 x 1012 or by email at scott.izyk@fda.hhs.gov.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1
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