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WARNING LETTER

Aaa International Seafood Corp. MARCS-CMS 718535 —

Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Shang Hung Chen
Recipient Title
Owner
Aaa International Seafood Corp.

2535 E 28th St
Vernon, CA 90058-1429
United States

office@aaainternationalseafood.com
Issuing Office:
Human Foods Program

United States

November 20, 2025

WARNING LETTER

Re: CMS # 718535

Dear Mr. Shang Hung Chen:

The United States Food and Drug Administration (FDA) conducted an inspection at your seafood processing and importer establishment facility, located at 2535 E 28th St. Vernon, CA 90058-1429 from March 26, 2025, through April 15, 2025. During our inspection of your facility, the FDA investigators found 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).

Based on FDA’s inspectional findings, we determined that your fresh Tuna and fresh Salmon intended to be consumed cooked or raw, are 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), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Furthermore, 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 Act [21 U.S.C. § 342(a)(4)].

Additionally, as an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. 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 products have been processed under conditions 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 Act, [21 U.S.C. § 342(a)(4)].

You may find the Act and further information about FDA’s regulations through links in FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection, the FDA investigator issued an FDA 483 (FDA-483), Inspectional Observations, listing the violations found at your facility. You provided responses to the FDA-483 on April 25, 2025, July 23, 2025, and July 24, 2025, which included a description of corrective actions taken by your firm. After reviewing the inspectional findings and your firm’s response, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.

Your significant violations were as follows:

Seafood HACCP (21 CFR Part 123)

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for fresh Tuna (Aquaculture) dated “04/15/25” does not list the critical control point of processing for controlling the food safety hazards of Scombrotoxin (Histamine). FDA recommends processors of ready-to-eat (RTE) seafood control the time in which scombroid species are held at ambient temperatures above 40°F during processing.

2. 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for fresh Tuna (Aquaculture) dated “04/15/25” does not list the food safety hazard of undeclared major food allergens. FDA recommends that processors of finfish ensure each product is properly labeled to control undeclared allergens. Additionally, tuna was observed packaged in salmon boxes on March 31, 2025, creating cross-labeling concerns.

3. 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 fresh Tuna (Aquaculture), dated “4/15/25” intended to be consumed cooked or raw, lists a critical limit, internal temperature of fresh tuna must not exceed (b)(4)°F, at (b)(4) critical control point that is not adequate to control pathogens hazard. Your firm’s HACCP plan for fresh Salmon (Aquaculture), dated “4/15/25” intended to be consumed cooked or raw, lists a critical limit, internal temperature of fresh salmon must not exceed (b)(4)°F at receipt, is not adequate to control pathogens hazard. FDA recommends that processors of RTE fish received on gel packs not only ensure the internal temperature of the fish is below 40°F, but also that there is adequate quantity of cooling media remaining frozen throughout transit. In addition, your firm should ensure a representative number of fish are checked for proper internal temperature at receipt. Furthermore, for the shipment of fresh tuna shipped on or around March 20, 2025 from Spain, you do not have an entry for the receiving temperature of the fresh tuna received between March 22 – 27, 2025 as well as no receiving temperature record for salmon from Faroe Islands (shipped around March 18, 2025, received between March 22-27, 2025).

4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the package/label critical control point to control undeclared allergens listed in your HACCP plan for fresh Salmon (Aquaculture), dated “4/15/25”. On July 24, 2025, your firm provided a copy of “(b)(4)”; however it does not document if you conducted visual examination at the beginning and hourly thereafter, outlined in your HACCP Plan for Salmon (Aquaculture), dated “4/15/25”.

5. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for fresh Tuna (Aquaculture), dated “4/15/25” at the (b)(4) critical control point to control Scombrotoxin (Histamine) is not appropriate. Your HACCP plan for Tuna (Aquaculture) has corrective actions for the critical control point at (b)(4) which states, “(b)(4).” FDA does not recommend placing incoming refrigerated fish on ice when the critical limit is exceeded because it is unknown how long the fish remained above 40°F during transit; therefore, reducing the temperature at receiving does not ensure the safety of the scombroid species fish.

6. You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for fresh Salmon (Aquaculture) from Faroe Islands. Your firm does not maintain written import verification procedures, product specifications and an affirmative step for fresh and RTE Salmon manufactured by Bakkafrost Processing in Faroe Islands.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations 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 applicable FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action 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 fifteen (15) working days of receipt of this letter, of the specific steps and corrections 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 fifteen (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: Liza Quiles, Compliance Officer, via email at Liza.Quiles@fda.hhs.gov or via mail to Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Liza Quiles, Compliance Officer via email at: Liza.Quiles@fda.hhs.gov. . Please include reference #718535 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, J.D. M.B.A.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Food and Drug Administration

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