FDA 483 - Kovas Co., Ltd. - November 22, 2019

An FDA inspection conducted at Kovas Co., Ltd., an Over-the-Counter (OTC) drug manufacturer in Paju, Gyeonggi, Republic of Korea, from November 18-22, 2019, resulted in 22 observations listed on Form FDA 483. These observations highlight significant deviations from Current Good Manufacturing Practices (cGMP) for drug products. Key issues identified primarily concern data integrity and laboratory controls. The firm failed to validate computerized systems like HPLC software, lacked appropriate controls to prevent unauthorized data modification or deletion, and did not maintain backup files for electronic data. Laboratory testing was found deficient, with issues including incorrect reference standards, absence of growth promotion testing for culture media, and inadequate microbial analysis methods. Further observations related to production and quality management. The stability testing program was not followed, equipment maintenance schedules were absent, and equipment use logs were not maintained. Documentation deficiencies included a lack of reserve samples for active ingredients, missing labeling samples in batch records, and the quality unit not adhering to its own procedures for change and document control. Notably, employees involved in production and quality control had not received routine cGMP training. Kovas Co., Ltd. is required to address these inspectional observations by implementing comprehensive corrective and preventive actions to ensure full compliance with regulatory standards for drug manufacturing.