Warning Letter Record: Huons Co., Ltd. (2026-06-15) — CGMP/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
In short: FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Huons Co., Ltd. on 2026-06-15 regarding CGMP/Finished Pharmaceuticals/Adulterated. The letter references 21 CFR 211.194(a). The verbatim letter is published on fda.gov.
Argus analysis
Huons Co., Ltd. received a Warning Letter from FDA's Center for Drug Evaluation and Research (CDER), dated 2026-06-15, regarding CGMP/Finished Pharmaceuticals/Adulterated. The letter follows an FDA inspection and is classified by Argus HQ as critical severity, consistent with Current Good Manufacturing Practice violations under 21 CFR Part 211 (drugs) or Part 600 (biologics).
The published letter cites 21 CFR 211.194(a). Warning Letters citing these sections generally concern Current Good Manufacturing Practice violations under 21 CFR Part 211 (drugs) or Part 600 (biologics), typically covering component testing, cleaning validation, laboratory controls, or investigation of out-of-specification results. The full citation language and supporting observations are in the verbatim letter linked below — Argus HQ does not add citations beyond what FDA published.
FDA Warning Letters carry a 15-business-day response window for the recipient to detail corrective actions. Peer compliance teams in the same product category typically use a letter like this one as an external audit trigger, checking whether their own quality system has documented coverage for the cited sections and whether their CAPA log would withstand the same line of inspection questioning.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
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 Huons Co., Ltd. MARCS-CMS 724650 — June 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Return Receipt Requested Reference #: 320-26-95 Product: Drugs Recipient: Recipient Name Mr. Jeong-woo Choo Recipient Title Site Head Huons Co., Ltd. 100 Bio Valley-ro Jecheon-si Chungcheongbuk-do 27159 South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-95 June 15, 2026 Dear Mr. Choo: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Huons Co., Ltd., FEI 3007163376, located at 100 Bio Valley-ro, Jecheon, Chungcheongbuk, from November 12 to 21, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your December 15, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations including, but not limited to, the following. 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records lacked complete and original data to support the analyses performed. For example: A. During the inspection, we requested the testing worksheets from the (b)(4) studies you conducted on a compounding tank and its transfer line, which included endotoxin and bioburden tests. Initially, your firm provided only a portion of the data. The following day, your firm’s management informed our investigator of critical breaches in data integrity. The first (b)(4) run failed endotoxin limits, and the second (b)(4) run revealed significant bioburden levels. However, your team leader had instructed staff to discard the bioburden plates with significant growth and had manipulated camera timestamps to create backdated documentation. In addition, the endotoxin failure had not been documented or investigated. B. During the walkthrough of your microbiology laboratories, we found 1,897 blank uncontrolled CGMP-related forms. C. Pages were removed from your logbook and replaced with newly fabricated pages. Your microbiology team leader admitted to using a knife to remove completed pages from the logbook. Logbook pages were then manipulated to look like the originals, and the microbiology team leader instructed the analyst to backdate and omit testing information related to bioburden samples…
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 Huons Co., Ltd. cited for?
- The FDA Warning Letter to Huons Co., Ltd. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Huons Co., Ltd.?
- FDA issued the letter (MARCS-CMS 724650) on 2026-06-15 and posted it publicly on fda.gov on 2026-06-23.
- Is the FDA warning letter to Huons Co., Ltd. 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/huons-co-ltd-724650-06152026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
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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). Warning Letter Record: Huons Co., Ltd. (2026-06-15) — CGMP/Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-huons-co-ltd-2026-06-15-cgmp
"Warning Letter Record: Huons Co., Ltd. (2026-06-15) — CGMP/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-huons-co-ltd-2026-06-15-cgmp.
Argus HQ Research. "Warning Letter Record: Huons Co., Ltd. (2026-06-15) — CGMP/Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-huons-co-ltd-2026-06-15-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_huons_co_ltd_2026_06_15_cgmp_2026,
title = {Warning Letter Record: Huons Co., Ltd. (2026-06-15) — CGMP/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-huons-co-ltd-2026-06-15-cgmp},
note = {Accessed: July 13, 2026}
}