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 by hand 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 its review and approval sections since January 2017, according to the supervisor.
The firm’s quality control unit invalidated out-of-specification test results without scientific justification, the investigator noted. An OOS standard operating procedure did not require conducting a hypothesis study and had no requirement for finding the root cause.
Facility staff invalidated OOS results without calculating test results and reviewing data. No justification was given for missing chromatograms, no hypothesis study was conducted and original test results were not reported. There was also no analysis to find the root cause or any corrective and preventive action initiated.
Employee training also did not meet the function and written procedure requirements of CGMP regulations. Specifically, quality control supervisors for finished products and raw material testing were not trained to conduct investigations related to OOS, out-of-trend and deviations. They failed to conduct related investigations and did not follow training related to GMP and data integrity for timely review and approval of instrument usage logbooks, laboratory test data and other items.
The firm also lacked scientifically sound standards, sampling plans or test procedures to assure in-process materials and products conform to quality standards. The facility had no audit trail for systems used to test over-the-counter products sold in the U.S., and raw data was not documented or kept by the firm during analysis, including sample and standard weights and
The firm also did not validate in-house test methods used to test raw materials, finished products and stability samples of products sent to the U.S. market, the agency said.