FDA 483 - Sionc Pharmaceuticals Private Limited - August 02, 2019

An FDA inspection of Sync Pharmaceuticals Pvt. Ltd., an API manufacturer in Parawada, India, revealed significant deficiencies in their quality control unit and cleaning process validation. Inspectors found inadequate controls over electronic data, including unpassworded hard drives and shared computer logins, raising concerns about data integrity. Additionally, the firm failed to adequately document cleaning process validation, with inconsistent surface area calculations lacking justification.