FDA 483 - Kinkando Co., Ltd - November 09, 2018

Kinkando Co., Ltd in Honjo, Japan, an OTC drug manufacturer, was inspected by the FDA from November 6-9, 2018. The inspection revealed significant deficiencies across laboratory, production, and quality systems, including issues with data integrity, recordkeeping, equipment identification, yield calculations, and quality control unit responsibilities. These observations indicate a lack of adherence to good manufacturing practices.