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# CGMP Violations at Korea’s Celltrion
- URL: https://www.fdaweb.com/cgmp-violations-at-koreas-celltrion/
- Published: 2018-02-06T12:00:00.000Z
- Updated: 2026-09-14T23:20:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140692

A 5/22-6/2/17 FDA inspection at Celltrion, Inc., Incheon, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 1/26 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm594395.htm?ref=fdaweb.com). Specific violations cited were: 

- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and including validation of all aseptic and sterilization processes;
- 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 establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The letter says the company’s responses to the inspection observations were inadequate. “Based upon the nature of the violations we identified at your firm,” the letter says, “we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements. In particular, the consultant should comprehensively assess your investigation and trending systems, aseptic processing line hazards, the media fill program, and the quality of batches produced for the United States.”

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