FDA EIR - Kovas Co., Ltd. - July 16, 2023

The Food and Drug Administration (FDA) conducted an initial Current Good Manufacturing Practice (CGMP) inspection of Kovas Co., Ltd., an Over-the-Counter (OTC) drug manufacturer, from November 18 to November 22, 2019. This inspection, performed under Compliance Program 7356.002 for drug manufacturing, encompassed all six key operational systems: Quality, Facilities and Equipment, Laboratory Control, Materials, Production, and Packaging and Labeling.

The inspection identified 22 significant issues, documented on an FDA-483 form. Major violations included inadequate validation of software programs used for product analysis, insufficient access controls and data backup for electronic systems, and incorrect use of reference standards. There were also deficiencies in microbial analysis, failure to adhere to stability study programs, and issues with equipment design, maintenance, and logging. Material control weaknesses involved improper sampling of raw materials and components, and inadequate management of reserve samples. Furthermore, the company exhibited shortcomings in packaging batch record content, quality assurance oversight of controlled documents, compliance with master batch record procedures, establishment of yield percentages, and comprehensive employee training on CGMP.

Kovas Co., Ltd. management acknowledged these findings and committed to implementing corrective actions. They promised to submit a detailed written response to the FDA within fifteen working days.