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# 4 CGMP Violations in Huons Inspection
- URL: https://www.fdaweb.com/4-cgmp-violations-in-huons-inspection/
- Published: 2026-06-23T12:00:00.000Z
- Updated: 2026-09-14T13:41:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161353

A 11/12-11/21/2025 FDA inspection at the Huons Co. drug manufacturing facility in Jecheon, Chungcheongbuk, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/huons-co-ltd-724650-06152026?ref=fdaweb.com) says the four specific violations were:

- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failure to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
- failure to establish an adequate system for maintaining equipment used to control the aseptic conditions.

FDA says that significant findings in the letter demonstrate the firm does not operate an effective quality system that follows CGMP. Further, it says, in addition to the lack of management oversight of the laboratory and production operations, the agency found the firm’s quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.

The letter recommends that Huons contract with a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

FDA acknowledges the company’s commitment to suspend production of all drugs at the facility for the U.S. market. The company committed to a recall of all its drugs from the U.S. market due to the CGMP issues. FDA asked to be informed whether Huons intends to resume producing drugs for the U.S. market. It placed all of the company’s products on a 4/3 Import Alert.

Huons was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.