Kolmar Korea Cited for Slew of Violations

The FDA hit Kolmar Korea with a Form 483 over numerous violations — including negligent handling of documents, lack of employee training and failure to conduct process validation — after a September inspection of its Sejong City, South Korea facility.

The inspector observed numerous GMP documents torn up in the firm’s main trash area, including batch production records, master batch production records, laboratory reports and certificates of analysis, and electronic documents and spreadsheets found in workstation recycle bins could not be explained.

A quality control analyst at the facility attempted to run away with a gas chromatography column usage log sheet concealed in his apron. The log sheets lacked appropriate signatures for review and approval sections since January 2017, according to the supervisor.