AF Import & Wholesale Co — FDA Warning Letter, 2026-05-26: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Letter issued · posted to fda.gov .
Subject as published: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
TL;DR
Here's the summary: On May 26, 2026, the FDA issued a warning letter to AF Import & Wholesale Co (President Andy Luu), Houston, TX, citing serious violations of seafood HACCP regulations (21 CFR Part 123) identified during inspections April 29-30, 2026 and August 28-29, 2019. The firm failed to implement written verification procedures and product specifications for imported seafood, did not provide evidence that imported fishery products were processed under HACCP-compliant conditions, and the violations represent a repeat observation from the 2019 inspection. The FDA stated the imported products appear adulterated under the Federal Food, Drug, and Cosmetic Act and may be subject to detention, seizure, or refusal of admission unless violations are corrected within 15 working days.
Argus analysis
# FDA Warning Letter Analysis: AF Import & Wholesale Co
**Company and Violations**
AF Import & Wholesale Co, a seafood importer headquartered in Houston, Texas, received a warning letter from the FDA's Office of Inspections and Investigations on May 26, 2026, following inspections conducted April 29–30, 2026. The FDA identified serious violations of seafood safety regulations during the inspection. The agency determined that imported seafood products were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to processing, packing, or storage under insanitary conditions that could render products injurious to health.
**Regulatory Citations and Their Meaning**
The violations center on 21 CFR Part 123, the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, with specific focus on 21 CFR 123.12(a)(2)(ii) and 123.12(d). These sections require importers to maintain written verification procedures and product specifications that confirm imported seafood was processed under conditions equivalent to domestic standards. The agency found AF Import & Wholesale Co lacked these verification procedures for specified seafood products and could not provide evidence of HACCP-compliant processing at foreign suppliers. Notably, this violation repeated from an August 2019 inspection, indicating a pattern of non-compliance.
**Response Timeline and Industry Monitoring**
The company has 15 working days to respond in writing with a corrective action plan and supporting documentation. The FDA indicated potential next steps include detention without physical examination, product seizure, or injunction against further violations. Compliance officers in seafood import should note that repeat violations strengthen FDA's enforcement posture. Close monitoring of the company's public response and any subsequent import denials will signal whether the corrective actions prove adequate.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER AF Import & Wholesale Co MARCS-CMS 730187 — May 26, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Andy Luu Recipient Title President AF Import & Wholesale Co 2201 Jefferson St Houston , TX 77003-5130 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States 05/26/2026 WARNING LETTER RE: CMS # 730187 Dear Mr. Luu: We inspected your seafood importer establishment, located at 2201 Jefferson St, Houston, TX 77003-5130 on April 29, 2026, through April 30, 2026. We also conducted an inspection on August 28, 2019, through August 29, 2019. 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 (b)(4) and (b)(4) 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 do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fishery products you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). This is a repeat observation from the previous inspection conducted 08/28/2019 through 08/29/2019 for the (b)(4) . Specifically, you do not have written verification procedures, product specifications, and an affirmative step for the importation of (b)(4) of (b)(4) imported from (b)(4) on (b)(4) , and (b)(4) of (b)(4) imported from (b)(4) on (b)(4) . You have not provided evidence that the fishery products you import have been processed under conditions that comply with the Seafood HACCP regulation. Specifically, your firm imp…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What FDA violations was AF Import & Wholesale Co cited for?
- The FDA Warning Letter to AF Import & Wholesale Co (issuing office: Office of Inspections and Investigations) cites: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to AF Import & Wholesale Co?
- FDA issued the letter (MARCS-CMS 730187) on 2026-05-26 and posted it publicly on fda.gov on 2026-07-14.
- Is the FDA warning letter to AF Import & Wholesale Co publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/af-import-wholesale-co-730187-05262026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
argus.hq
Don’t find out about the next one six weeks late.
Argus reads every FDA Warning Letter the day it publishes, summarizes it against your watchlist, and lands the ones touching your business in your inbox at 6am ET. Plans from $99/month. Cancel any time.
methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). AF Import & Wholesale Co — FDA Warning Letter, 2026-05-26: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-af-import-and-wholesale-co-2026-05-26-cgmp
"AF Import & Wholesale Co — FDA Warning Letter, 2026-05-26: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-af-import-and-wholesale-co-2026-05-26-cgmp.
Argus HQ Research. "AF Import & Wholesale Co — FDA Warning Letter, 2026-05-26: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions." Digital Empire Holdings LLC. Accessed July 18, 2026. https://argushq.ai/fda/warning-letter/fda-wl-af-import-and-wholesale-co-2026-05-26-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_af_import_and_wholesale_co_2026_05_26_cgmp_2026,
title = {AF Import & Wholesale Co — FDA Warning Letter, 2026-05-26: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-af-import-and-wholesale-co-2026-05-26-cgmp},
note = {Accessed: July 18, 2026}
}