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# CGMP Violations in Kolmar Korea Co. Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-kolmar-korea-co-inspection/
- Published: 2018-06-05T12:00:00.000Z
- Updated: 2026-09-15T00:10:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141601

A 9/25-9/28 FDA inspection at Kolmar Korea Co., Sejong-si, South Korea, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 5/18 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609136.htm?ref=fdaweb.com). Specific violations listed in the letter are: 

- failing 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 has already been distributed; and
- failing to follow written procedures applicable to the quality control unit.

The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.