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

An FDA inspection of Kovas Co., Ltd., an Over-the-Counter (OTC) drug manufacturer, was conducted from November 18-22, 2019. This routine Current Good Manufacturing Practice (CGMP) inspection, performed under Compliance Program 7356.002, covered all six critical systems: Quality, Facilities and Equipment, Laboratory Control, Materials, Production, and Packaging and Labeling. The inspection concluded with the issuance of a 22-item FDA-483, detailing significant observations. Key issues included failures in software validation, electronic system access control, and data backup. Laboratory controls were deficient, with improper reference standards, incomplete testing of received components, and inadequate microbial analysis methods and reference standard characterization. Equipment design, maintenance, and logging were found lacking, alongside the use of uncalibrated weights. Material management issues encompassed improper sampling of raw materials and components, and inadequate maintenance and visual verification of reserve samples. Furthermore, documentation and quality assurance problems involved incomplete packaging batch records, insufficient control over records and procedures, and unestablished yield percentages. Finally, employee training on CGMP requirements was identified as insufficient. Kovas Co., Ltd. management acknowledged these observations and committed to providing a written response with proposed corrections within fifteen working days.