In brief, the facility failed to set and maintain critical limits for temperature control. The storage coolers for mollusks and pasteurized crab meat did not have proper temperature settings. The
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/euro-usa-inc-666173-11222023
Euro USA Inc
MARCS-CMS 666173 — NOVEMBER 22, 2023
Recipient:
Mr. Joseph O’Donnell
Chief Executive Officer
Euro USA Inc
4481 Johnston Parkway
Cleveland, OH 44128
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
WARNING LETTER 666173
November 22, 2023
Dear Mr. O’Donnell:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 4481 Johnston Parkway, Cleveland Ohio from July 10 to July 25, 2023. 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, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). 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 fish and fishery products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby it 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.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations. You provided a written response to the inspection on August 11, 2023, which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your HACCP program.
Your significant deviations are as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plans for Combined Molluscan Shellfish that includes your shucked, raw scallops in cans, Pasteurized Crabmeat and Scombroid Fish lists critical limits that are inadequate to control the hazards of Clostridium botulinum, pathogenic growth and toxin formation and histamine formation.
a. At the storage critical control point for your Combined Molluscan Shellfish, which includes reduced oxygen packaged shucked raw scallops in cans, the listed critical limit is “Storage cooler temperature not to exceed (b)(4). However, a critical limit of (b)(4) is necessary to control C. botulinum growth and toxin formation
b. At the storage critical control point for your Pasteurized Crabmeat HACCP, the listed critical limit of “Storage cooler temperature should not exceed (b)(4) for over (b)(4). However, many of the cooler temperatures exceeded this critical limit in June and July 2023. Most notably, the temperature range was (b)(4) from July 2-8, 2023. In addition, your critical limit should ensure the products are (b)(4).
Furthermore, our investigator reviewed your continuous monitoring system (CMS) records for your seafood storage cooler. The CMS data records from May 20 to July 10, 2023, revealed your seafood storage cooler temperatures ranged from (b)(4) for entire days. Additionally, employees used infrared thermometer (IR) guns to monitor the same storage cooler temperatures and for the same time span, the IR temperature recordings were logged at (b)(4).
c. The receiving CCP for your Combined Molluscan Shellfish HACCP plan that includes your reduced oxygen packaged shucked raw, scallops in cans, lists a critical limit that fails to ensure the products were held at adequate temperatures continuously during transit to your facility (b)(4).
d. The receiving CCP for your Scombroid fish HACCP plan, lists a critical limit that is not adequate to control histamine formation. The critical limit indicates you may receive scombroid fish with gel packs. If so, FDA recommends internal temperatures of a representative number of fish be taken at receiving. Your written response indicated that you are revising your HACCP plans to reflect the correct CCP, and seafood staff have been trained on new procedures. We find your response inadequate in that you did not provide evidence/documentation to demonstrate your corrective actions or that employee training was performed.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b), (c)(4). However, your firm did not follow monitoring and verification procedures for your Combined Molluscan Shellfish, Scombroid Fish and Pasteurized Crabmeat HACCP plans. Specifically,
a. The monitoring procedure at the storage critical control point (CCP) for your Scombroid fish lists checking the adequacy of ice “(b)(4)”. However, your firm operates (b)(4). According to your Daily Seafood Sanitation Reports on June 3, 6, 13, 17, 18, 20, 24, and 25, 2023 and July 4, 8, and 9, 2023, the adequacy of ice was (b)(4). On June 11 and July 1-3, 2023, the adequacy of ice was not checked at all. Furthermore, the monitoring procedures don’t include taking the internal temperatures of fish to ensure the critical limit is met. The monitoring procedures don’t require a representative number of containers to be examined and the approximate number of containers in the cooler.
receiving CCP for the Combined Molluscan Shellfish HACCP plan that includes reduced oxygen packaged shucked raw, scallops in cans, lists a critical limit that fails to ensure the products were held at adequate temperatures continuously during transit to your facility. The CP for the Scombroid fish HACCP plan, lists a critical limit that is not adequate to control histamine formation.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/euro-usa-inc-666173-11222023
Euro USA Inc
MARCS-CMS 666173 — NOVEMBER 22, 2023
Recipient:
Mr. Joseph O’Donnell
Chief Executive Officer
Euro USA Inc
4481 Johnston Parkway
Cleveland, OH 44128
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
WARNING LETTER 666173
November 22, 2023
Dear Mr. O’Donnell:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 4481 Johnston Parkway, Cleveland Ohio from July 10 to July 25, 2023. 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, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). 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 fish and fishery products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby it 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.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations. You provided a written response to the inspection on August 11, 2023, which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your HACCP program.
Your significant deviations are as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plans for Combined Molluscan Shellfish that includes your shucked, raw scallops in cans, Pasteurized Crabmeat and Scombroid Fish lists critical limits that are inadequate to control the hazards of Clostridium botulinum, pathogenic growth and toxin formation and histamine formation.
a. At the storage critical control point for your Combined Molluscan Shellfish, which includes reduced oxygen packaged shucked raw scallops in cans, the listed critical limit is “Storage cooler temperature not to exceed (b)(4). However, a critical limit of (b)(4) is necessary to control C. botulinum growth and toxin formation
b. At the storage critical control point for your Pasteurized Crabmeat HACCP, the listed critical limit of “Storage cooler temperature should not exceed (b)(4) for over (b)(4). However, many of the cooler temperatures exceeded this critical limit in June and July 2023. Most notably, the temperature range was (b)(4) from July 2-8, 2023. In addition, your critical limit should ensure the products are (b)(4).
Furthermore, our investigator reviewed your continuous monitoring system (CMS) records for your seafood storage cooler. The CMS data records from May 20 to July 10, 2023, revealed your seafood storage cooler temperatures ranged from (b)(4) for entire days. Additionally, employees used infrared thermometer (IR) guns to monitor the same storage cooler temperatures and for the same time span, the IR temperature recordings were logged at (b)(4).
c. The receiving CCP for your Combined Molluscan Shellfish HACCP plan that includes your reduced oxygen packaged shucked raw, scallops in cans, lists a critical limit that fails to ensure the products were held at adequate temperatures continuously during transit to your facility (b)(4).
d. The receiving CCP for your Scombroid fish HACCP plan, lists a critical limit that is not adequate to control histamine formation. The critical limit indicates you may receive scombroid fish with gel packs. If so, FDA recommends internal temperatures of a representative number of fish be taken at receiving. Your written response indicated that you are revising your HACCP plans to reflect the correct CCP, and seafood staff have been trained on new procedures. We find your response inadequate in that you did not provide evidence/documentation to demonstrate your corrective actions or that employee training was performed.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b), (c)(4). However, your firm did not follow monitoring and verification procedures for your Combined Molluscan Shellfish, Scombroid Fish and Pasteurized Crabmeat HACCP plans. Specifically,
a. The monitoring procedure at the storage critical control point (CCP) for your Scombroid fish lists checking the adequacy of ice “(b)(4)”. However, your firm operates (b)(4). According to your Daily Seafood Sanitation Reports on June 3, 6, 13, 17, 18, 20, 24, and 25, 2023 and July 4, 8, and 9, 2023, the adequacy of ice was (b)(4). On June 11 and July 1-3, 2023, the adequacy of ice was not checked at all. Furthermore, the monitoring procedures don’t include taking the internal temperatures of fish to ensure the critical limit is met. The monitoring procedures don’t require a representative number of containers to be examined and the approximate number of containers in the cooler.
Your written response indicated that your HACCP plans are under review and will be revised. Additionally, your response indicated that employees were trained on proper monitoring procedures; however, a new HACCP plan hasn’t been implemented yet, nor was evidence provided to document employee training was performed. This response is inadequate in that corrective actions have not been taken or implemented. You also failed to offer a timeframe on when these revisions would be completed.
3. You must take appropriate corrective actions when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your corrective actions were not appropriate to control your hazards of pathogenic bacteria growth, toxin formation and C. botulinum toxin formation when your cooler temperatures for the storage of Pasteurized Crabmeat and your shucked shellfish meat deviated from your listed critical limits of “Storage cooler temperature should not exceed (b)(4) for over (b)(4)” and “Storge cooler temperature not to exceed (b)(4)”, respectively.
Furthermore, your trained Seafood HACCP employee reviewed your CMS records that revealed critical limit deviations and failed to evaluate the product or conduct any type of corrective actions.
Your written response indicated that employees were trained on the importance of performing necessary corrective actions; however, you failed to provide evidence that employee training was performed.
4. Your HACCP plans include corrective action plans that are not in accordance with 21 CFR 123.7(b) to ensure affected product is not entered into commerce and the cause of the deviation was corrected as required by 21 CFR 123.6(c)(5). Specifically,
a. The CCP of cooler storage of fresh shucked shellfish meat for you Combined Molluscan Shellfish and Pasteurized Crabmeat HACCP plans are inadequate to control Clostridium botulinum growth and toxin formation. Your HACCP plans do not list corrective actions on evaluating the cumulative time and the ambient cooler temperature exposures of the affected product, rejecting the lot or diverting to a non-food use.
b. The CCP’s of receiving and Finished Product Storage in the Scombroid Fish HACCP plan are inadequate to control histamine formation. Taking the internal product temperature alone at receiving does not control the hazard. Additionally, waiting until the finished product storage cooler temperature is above (b)(4) for more than (b)(4), checking the adequacy of ice and product temperature does not control the hazard. Furthermore, the HACCP plan doesn’t document chilling, holding, rejecting or diverting the lot to non-food use.
Your written response indicated that your HACCP plans are under review. This response is inadequate in that corrective actions have not been taken or implemented. Additionally, you failed to offer a timeframe on when these revisions would be completed.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs) to comply with 21 CFR 123.11 (b). However, your firm did not monitor for the adequacy of key areas of sanitation (b)(4) on June 3, 9, 13, 17, 18, 20, 24, 25 and July 4, 8 and 9, 2023. Additionally, you failed to check the adequacy of any key areas of sanitation at all on June 11 and July 1-3, 2023.
Your written response indicated that employees were trained to check and record sanitation conditions and practices (b)(4) per shift; however, you failed to provide evidence that employee training was performed or adequately completed “Daily Seafood CCP and Sanitation Report” forms.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Please send your reply to the Food and Drug Administration, Attention: Allison Hunter, Compliance Officer, 550 Main Street, Suite 4-930, Cincinnati, Ohio 45202. If you prefer to send your response electronically, please email it to ORAHAFEAST5FirmResponses@fda.hhs.gov. If you have any questions regarding this letter, please contact Allison C. Hunter, Compliance Officer, at Allison.hunter@fda.hhs.gov or (513) 322-0629.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
3. You must take appropriate corrective actions when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your corrective actions were not appropriate to control your hazards of pathogenic bacteria growth, toxin formation and C. botulinum toxin formation when your cooler temperatures for the storage of Pasteurized Crabmeat and your shucked shellfish meat deviated from your listed critical limits of “Storage cooler temperature should not exceed (b)(4) for over (b)(4)” and “Storge cooler temperature not to exceed (b)(4)”, respectively.
Furthermore, your trained Seafood HACCP employee reviewed your CMS records that revealed critical limit deviations and failed to evaluate the product or conduct any type of corrective actions.
Your written response indicated that employees were trained on the importance of performing necessary corrective actions; however, you failed to provide evidence that employee training was performed.
4. Your HACCP plans include corrective action plans that are not in accordance with 21 CFR 123.7(b) to ensure affected product is not entered into commerce and the cause of the deviation was corrected as required by 21 CFR 123.6(c)(5). Specifically,
a. The CCP of cooler storage of fresh shucked shellfish meat for you Combined Molluscan Shellfish and Pasteurized Crabmeat HACCP plans are inadequate to control Clostridium botulinum growth and toxin formation. Your HACCP plans do not list corrective actions on evaluating the cumulative time and the ambient cooler temperature exposures of the affected product, rejecting the lot or diverting to a non-food use.
b. The CCP’s of receiving and Finished Product Storage in the Scombroid Fish HACCP plan are inadequate to control histamine formation. Taking the internal product temperature alone at receiving does not control the hazard. Additionally, waiting until the finished product storage cooler temperature is above (b)(4) for more than (b)(4), checking the adequacy of ice and product temperature does not control the hazard. Furthermore, the HACCP plan doesn’t document chilling, holding, rejecting or diverting the lot to non-food use.
Your written response indicated that your HACCP plans are under review. This response is inadequate in that corrective actions have not been taken or implemented. Additionally, you failed to offer a timeframe on when these revisions would be completed.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs) to comply with 21 CFR 123.11 (b). However, your firm did not monitor for the adequacy of key areas of sanitation (b)(4) on June 3, 9, 13, 17, 18, 20, 24, 25 and July 4, 8 and 9, 2023. Additionally, you failed to check the adequacy of any key areas of sanitation at all on June 11 and July 1-3, 2023.
Your written response indicated that employees were trained to check and record sanitation conditions and practices (b)(4) per shift; however, you failed to provide evidence that employee training was performed or adequately completed “Daily Seafood CCP and Sanitation Report” forms.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Please send your reply to the Food and Drug Administration, Attention: Allison Hunter, Compliance Officer, 550 Main Street, Suite 4-930, Cincinnati, Ohio 45202. If you prefer to send your response electronically, please email it to ORAHAFEAST5FirmResponses@fda.hhs.gov. If you have any questions regarding this letter, please contact Allison C. Hunter, Compliance Officer, at Allison.hunter@fda.hhs.gov or (513) 322-0629.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
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