FDA 483 - Accrete Pharmaceuticals Private Limited - May 16, 2018

An FDA inspection of Accrete Pharmaceuticals Private Limited, an intermediate manufacturer in Yadadri Bhuvanagiri District, Telangana, India, revealed significant deficiencies in quality control. Observations included a lack of verification for testing methods, failures in quality unit procedures for data review and vendor qualification, and inadequate retention sample management. These issues highlight a need for improved quality system oversight and documentation.