FDA Cites Huons Co., Ltd. in June 15, 2026 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at Huons Co., Ltd.

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. Your response indicates that multiple personnel involved in data manipulation are no longer employed at your firm, and you have established a data integrity team to help oversee microbiology laboratory data practices. We also acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. Your response is inadequate because it does not provide a corrective action and preventive action (CAPA) plan with sufficient actions to systemically implement management oversight and assure data integrity. In your initial response to inspectional findings your firm contracted a third party to perform an assessment to adequately determine the extent of your firm’s data integrity issues. You initially committed to providing the interim and final reports of this assessment. However, you later informed the FDA that this document would be classified as an “internal audit”, and that reports would not be provided. The agency disagrees w