FDA 483 - Kolmar Korea Co., Ltd. - Gwanjeong Factory - February 16, 2024

An FDA inspection was conducted at Kolmar Korea Co., Ltd. - Gwanjeong Factory from February 8 to February 16, 2024. The inspection identified multiple deviations from current Good Manufacturing Practices (cGMP) for drug products, impacting the quality and safety of over-the-counter (OTC) drugs manufactured for the U.S. market. Significant violations included inadequate documentation for microbiology testing, where essential details like sample preparation, incubation parameters, and equipment calibration were not recorded. The firm also failed to perform specific microbial tests for purified water and lacked efficacy testing for an OTC product. Batch production records were deficient, missing real-time entries for manufacturing steps and equipment cleaning, and periodic cleaning verification for shared production equipment was not conducted. Data integrity in the quality control laboratory was compromised, as electronic data from various analytical instruments was vulnerable to deletion, with audit trails failing to record such changes. Furthermore, the company had not established impurity specifications for its OTC drug products, shipping numerous batches without this crucial quality assessment. Product traceability was also an issue, with different formulations assigned identical batch numbers, directly violating internal standard operating procedures. Lastly, raw materials were found to be improperly stored, leading to contamination risks that the firm's internal inspections failed to detect. Kolmar Korea Co., Ltd. is required to address these observations by submitting a comprehensive response detailing the corrective and preventive actions implemented or planned to ensure compliance with regulatory standards.