WARNING LETTER
Golden Shrimp Seafood Joint Stock Company
MARCS-CMS 682535 —
May 13, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Phuc T. Vo
Recipient Title
Company Director
Golden Shrimp Seafood Joint Stock Company
Hoa Phau Hamlet, Thuan Yen Village
03, National Road 80th, Group
Ha Tien Town
Kien Giang Province
920000
Vietnam
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
May 13, 2024
WARNING LETTER
Reference #: CMS 628535
Dear Mr. Vo,
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Lot A13 An Phu Industrial Zone, Tuy Hoa, Phu Yen, Vietnam 560000, on December 11 and 12, 2023. This inspection was conducted as a follow-up to a consumer complaint, which involved histamine poisoning from a saku, cubed, and ground yellowfin tuna product. During the inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing the deviations found at your firm. We received your responses on December 22, 26, and 27, 2023, which included corrective actions, product testing, and updated raw ingredient sampling procedures for histamine. However, our evaluation of the documentation provided in your responses revealed that your response was not adequate, as further described in this letter.
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 frozen histamine-forming seafood yellowfin tuna (Thunnus albacares) products are adulterated in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the June 2022 Edition of the Fish and Fishery Products Hazards and 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 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 plan for “Frozen Yellowfin Tuna CO/TS Treated, Cut into Loin, Saku, Cube, Steak, Strip, Crazy, Portions”, dated 25/09/2022, does not list adequate critical limits at the “
(b)(4)
” critical control point to control the food safety hazard of scombrotoxin (histamine) formation. Specifically:
a. You list a critical limit of “
(b)(4)
”. However, this critical limit does not provide adequate assurance that your procedures for sampling are representative of all fish in the sample.
b. You do not list a critical limit for when the fish are offloaded from the harvest vessels. For guidance and control strategies, you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 4th Edition at https://www.fda.gov/media/80648/download, Chapter 17 for
Scrombrotoxin (Histamine) Formation
.
During the inspection, you informed our investigator that you sample your fish from three portions, including along a one-inch plate at the back of the fin, in the front of the fin, and in front of the fish’s tail. In large scombrotoxin-forming fish, FDA recommends sampling from the lower, anterior (forward) portion of the fish loin (not the belly flap) to provide the best information about the histamine content of the fish. Although you provided corrective actions including updated raw ingredient sampling procedures for histamine, with supporting photographs identifying sampling locations in your response; you did not provide an updated HACCP plan, or any supporting documentation showing the incorporation and implementation of your updated sampling procedures into your HACCP program for our review. Therefore, regarding your updated sampling practices, we cannot evaluate the adequacy of your corrective actions.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
If you do not respond or if we find your response inadequate, we may take further action. 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 (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. In addition to your current placement on the “Red List” of Import Alert #16-105, "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/ Shippers Due to Decomposition and/or Histamine, and/or Indole", as published 12/19/2022, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120, “Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP". You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
Additionally, we offer the following comments:
Although you provided an updated CCP monitoring record entitled “
(b)(4)
” in your response, it does not appear adequate to document compliance with receiving critical limits because it does not allow for the recording of individual monitoring observations. For example, the record has 3 separate rows for recording “
(b)(4)
.”; however, the subsequent columns labeled “
(b)(4)
,” do not allow for the documentation of each individual observation on the line(s).
Your HACCP plan for “Frozen Yellowfin Tuna CO/TS Treated, Cut into Loin, Saku, Cube, Steak, Strip, Crazy, Portions” dated 25/09/2022, lists a monitoring procedure to make “
(b)(4)
” for “
(b)(4)
” for the critical limit of “
(b)(4)
” critical control point. This monitoring procedure does not include actual values and/or observations to adequately assure that the critical limit is met.
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 taking to correct these violations. More specifically, your response should include documentation such as your revised HACCP plan, 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 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 the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at amy.glynn@fda.hhs.gov. Please reference CMS # 628535 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Ann Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
11/19/2024
Regulated Product(s)
Food & Beverages