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  5. Ocean Green Seafood Inc. - 508823 - 10/18/2016
  1. Warning Letters

WARNING LETTER

Ocean Green Seafood Inc. MARCS-CMS 508823 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. James Ho
Recipient Title
President
Ocean Green Seafood Inc.

4988 Corona Avenue
Vernon, CA 90058-3212
United States

Issuing Office:

United States



WARNING LETTER
WL# 2-17


October 18, 2016

Dear Mr. Ho,

We inspected your seafood importer establishment, located at 4988 Corona Avenue, Vernon, CA 90058 on 19 September 2016. 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 frozen tuna, fresh salmon and fresh whole perch 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 were as follows:

• You did not comply with 21 CFR 123.12(a)(2), in that you did not have written verification procedures in place to ensure that the fish and fishery products you offered for importation into the United States were processed in accordance with the requirements of 21 CFR 123.

Specifically, your firm did not have written verification procedures (including product specifications and affirmative steps) for the following fish and fishery products:

    o Frozen tuna products processed and packed by Dalian Hualian Food Co., Ltd, Dalian, China
    o Fresh salmon products packed by Grieg Seafood Rogaland AS, Norway
    o Fresh whole perch products produced by Sea Drift Fish Co., Ltd, Nanaimo, British Columbia

Additionally, we are in receipt of your 21 September 2016 correspondence, by which you responded to the observations noted during the 19 September 2016 inspection of your facility.

Upon review of your correspondence, and the attachments contained therein, we have determined that your response is inadequate in addressing the noted observations, as follows:

    o The HACCP Import Evaluation Checklist, Product Specification sheet, and Supplier's Guarantee Letter are blank, and do not reference any fish or fishery products
    o The Import Verification of Seafood Products Standard Operating Procedures document does not reference specific fish or fishery prodl,lcts imported into the United States by your firm. Instead, the document reads, in part: "(b)(4)" [sic], "(b)(4)" , "(b)(4)", and that "(b)(4)" [sic].

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:

Daniel Solis
Director, Import Operations Branch
U.S. Food & Drug Administration
One World Trade Center, Suite 300
Long Beach, CA 90831

If you have questions regarding this letter, please contact James R. Miller, Compliance Officer at (562) 256-9211.

Sincerely,

/S/
CDR Steven E. Porter Jr.
Los Angeles District Director

 

Cc:

David M. Mazzera, Chief
Food and Drug Branch
California Department of Public Health
PO Box 997 435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413

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