FDA 483 - Daito Pharmaceutical Co., Ltd. - November 06, 2017

Daito Pharmaceutical Co., Ltd. in Toyama-City, Japan, a manufacturer of finished dosage drugs and APIs, was cited for significant deficiencies in laboratory controls, data integrity, record-keeping, and quality unit oversight. The inspection revealed issues including unreported trial analyses, inadequate supervisory review of electronic data, non-contemporaneous record completion, and insufficient control over GMP documents and change control procedures. These observations indicate a systemic breakdown in the firm's quality management system.