483
Zach System S.A.Zach System S.A. – FDA 483, Oct 25, 2018
Record Details
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.
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ID · 0ce3b68f-81a4-4147-834b-093ef620c932
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