FDA 483 - Zach System S.A. - October 25, 2018

An FDA inspection of Zach System S.A., an API manufacturer in Avrille Cedex, France, revealed deficiencies in laboratory control mechanisms. Specifically, the firm's electronic systems for product analysis lacked unique user access controls and protection against data deletion. These issues were observed with analytical instruments used for finished commercial API batches, indicating potential data integrity concerns.