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  5. Seafood Brothers Inc., DBA G & L Seafood Inc. - 656903 - 05/18/2023
  1. Warning Letters

WARNING LETTER

Seafood Brothers Inc., DBA G & L Seafood Inc. MARCS-CMS 656903 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Jason (NMI) Giang
Recipient Title
CEO
Seafood Brothers Inc., DBA G & L Seafood Inc.

2416 Chico Avenue
South El Monte, CA 91733-1613
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

May 18, 2023

Re: CMS # 656903

Dear Mr. Jason Giang:

We inspected your seafood importer establishment, 2416 Chico Avenue, South El Monte, CA 91733-1613 on March 23, 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 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your imported frozen whole cooked white clams from Vietnam, frozen whole clean headless white anchovies from Vietnam, and frozen whole aquaculture tilapia from Taiwan are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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 issued on a Form FDA 483, Inspectional Observations, dated March 23, 2023, are as follows:

1. You did not comply with 21 CFR 123.12(a)(2) in that you do not have and have not implemented written verification procedures, product specifications, and an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation. Specifically,

You do not have written verification procedures, product specifications, and or affirmative step for the Frozen Whole Clean Headless White Anchovy, and Frozen Whole Cooked White Clams both from the foreign processor (b)(4), in (b)(4).

For the Frozen Whole Tilapia, aquaculture from foreign processor, (b)(4), in (b)(4), your written verification procedure selected (b)(4) for the affirmative step but you had the foreign processor’s HACCP plan for Tilapia, aquaculture. However, you did not have the written guarantee from (b)(4), that the tilapia was processed in accordance with the Seafood HACCP regulations.

2. You did not comply with 21 CFR 123.12(d) in that you have not provided evidence that the fish you import have been processed under conditions that comply with the Seafood HACCP regulation. Specifically,

For the Frozen Whole Tilapia, aquaculture from foreign processor, (b)(4), in (b)(4), your product specification does not include parasite hazards, does not identify specific aquaculture drug hazards and specific tolerance and action levels for chemical hazards.

3. You did not comply with 21 CFR 123.9(a) in that your records do not include the date and time of the activity the record reflects and signature or initials of the person performing the operation. Specifically,

For the Frozen Whole Tilapia, aquaculture from foreign processor, (b)(4), in (b)(4), on June 29, 2022, your written verification procedure sections 1 and 2 were not completed and were not signed and dated.

We acknowledge receipt of your firm’s response to the Form FDA 483, issued at the close of our recent inspection on March 23, 2023. Your response does not adequately address our observations and we address your response below.

In your response, you provided documents collected during the inspection with minimal corrections, but you failed to provide a timeframe and plan of action that would bring your firm into compliance with the regulations. The documents submitted with your response are as follows:

  • (b)(4) HACCP plan titled, Frozen Aquaculture HACCP Plan that was uncorrected and remained inadequate in that it failed to correctly identify all significant species related hazards, critical control points (CCPs), and steps taken to minimize those hazards.

Specifically,

Tilapia, Oreochromis spp., aquaculture, has a Parasite Hazards that was not identified, no CCPs were listed, and no steps were taken to minimize that known hazard.

Milkfish, Chanos chanos, a Scombridae fish, has an unidentified Histamine Hazard that required CCPs at multiple steps in the process, steps to minimize the formation of histamine due to time and temperature abuse, and any corrective actions that could be taken.

The Agency’s review of the HACCP plan was stopped when the above significant deviations were observed and submitted uncorrected. Therefore, a comprehensive review was not conducted of all deviations that may exist with the HACCP Plan. It is the Importer’s responsibility to ensure that collected HACCP Plans are adequate to ensure their foreign supplier operates a mandatory safety program for all fish and fishery products according to the regulations.

  • (b)(4), was submitted as a corrective action, however, the document was inadequate as the firm failed to correctly identify all significant hazards (i.e., Parasites and Histamine formation of Scombridae fish), CCPs, and steps taken to minimize those hazards in its HACCP Plan. Therefore, there was no guarantee that the foreign supplier processed the imported seafood according to Seafood HACCP regulations and has implemented controls to ensure the imported seafood is safe for consumers in the U.S.
  • Product Specifications, Product Name: Tilapia, Farm-Raised, Oreochromis spp., was inadequate as it failed to correctly identify all significant hazards (i.e., Parasites), required steps taken by the foreign manufacturer to control that hazard, and steps taken by the importer to ensure the products meets their established specifications.
  • Importer Written Verification Procedures, (Including Determination of Compliance) was submitted with minimal corrections, i.e., signed and dated as steps completed. However, the document is inadequate as it failed to state in writing what actions were taken by the importer to ensure that the documents submitted by their foreign supplier were adequate to demonstrate the foreign manufacturer processed the imported seafood accordance with current Good Manufacturing Practices and were compliant with Seafood HACCP regulations.

Additionally, we note that in your response you did not provide Product Specifications and or affirmation steps for all the Seafood you import to demonstrated that they are not injurious to health or were not processed under insanitary conditions.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.

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 importer verification records and records that document the performance and results of your firm’s affirmative steps, 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 seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.

Please send your reply to the Food and Drug Administration, Attention: Attention: Lisa Capron, Compliance Officer, Division of West Coast Imports, 22215 26th Avenue SE, Ste. 210, Bothell, WA 98021 with a copy via electronic mail to WCID@fda.hhs.gov. Please reference CMS # 656903. If you have any questions regarding any issues in this letter, you may contact Lisa Capron at 425-302-0472 or via email to Lisa.Capron@fda.hhs.gov.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

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