https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dc-seafood-inc-617675-09152021
WARNING LETTER
D&C Seafood, Inc
MARCS-CMS 617675 — SEPTEMBER 15, 2021
Recipient:
Duong Tran
Co-Owner
D&C Seafood, Inc
391 Venice Boat Harbor Road
Venice, LA 70091
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
WARNING LETTER 617675
September 15, 2021
Dear Mr. Tran:
We inspected your seafood processing facility, located at 391 Venice Boat Harbor Road, Venice, LA 70091 on July 26, 2021. 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. 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 king mackerel, wahoo, barracuda, and cobia 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.External Link Disclaimer
Your significant violations were as follows:
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 1) king mackerel and wahoo to control the food safety hazards of histamine formation, 2) king mackerel and barracuda to control the hazard of ciguatera toxin, and 3) king mackerel, wahoo, barracuda, and cobia to control the hazard of undeclared allergens.
You did not submit a response to address these violations.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed product. 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 correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
Co-Owner
D&C Seafood, Inc
391 Venice Boat Harbor Road
Venice, LA 70091
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
WARNING LETTER 617675
September 15, 2021
Dear Mr. Tran:
We inspected your seafood processing facility, located at 391 Venice Boat Harbor Road, Venice, LA 70091 on July 26, 2021. 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. 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 king mackerel, wahoo, barracuda, and cobia 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.External Link Disclaimer
Your significant violations were as follows:
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 1) king mackerel and wahoo to control the food safety hazards of histamine formation, 2) king mackerel and barracuda to control the hazard of ciguatera toxin, and 3) king mackerel, wahoo, barracuda, and cobia to control the hazard of undeclared allergens.
You did not submit a response to address these violations.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed product. 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 correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
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