FDA EIR - Kovas Co., Ltd. - November 29, 2024

A routine FDA surveillance inspection of Kovas Co., Ltd., a foreign manufacturer of OTC drug products, was conducted from November 25-29, 2024. This inspection, carried out under Compliance Program 7356.002, evaluated the firm's Quality, Facilities and Equipment, Materials, Production, and Laboratory Systems. The inspection resulted in an eight-item FDA Form 483, highlighting critical deficiencies, some of which were repeat observations. Main violations included inadequate controls over computer systems like OpenLab ChemStation and OMNIC software, lacking proper user access, audit trail functionality, and validation to prevent unauthorized data manipulation. Laboratory controls were found deficient, with insufficient specifications, incomplete test data, and inadequate validation of test methods and supplier analyses for raw materials. The firm also failed to establish adequate written production and process control procedures, including homogeneity studies, and maintained incomplete batch records. Furthermore, the quality control unit's responsibilities were not fully implemented, particularly regarding deviation management and Out-of-Specification investigations. Equipment cleaning and maintenance practices were also deemed inadequate to prevent product contamination. Kovas Co., Ltd. management committed to submitting a written response to the FDA Form 483 within 15 business days.