FDA hits CDMO Kolmar Korea with warning letter over manufacturing issues

The FDA issued a warning letter to CDMO Kolmar Korea, citing significant GMP issues. (FDA)

The FDA issued a warning letter to Korean contract drug manufacturer Kolmar Korea, citing significant GMP issues stemming from an inspection conducted last September.

In a letter posted to the regulatory agency’s website, the FDA said inspectors found that the company failed to investigate out-of-specification results for certain lots of an over-the-counter cream and instead retested and invalidated the OOS results without justification.

Additionally, FDA inspectors said Kolmar Korea didn’t follow its own written procedures for document control, which require quality control unit approval for discarding records.


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“Our investigator observed documents and records, including batch production records, certificates of analysis, and laboratory worksheets, that were torn and discarded without documented quality unit approval,” according to the FDA letter.

Earlier this year, Kolmar Korea beat out private equity firms to snap up health foods and drugmaker CJ HealthCare, the maker of a popular South Korean anti-hangover drink, for $1.2 billion.