Sun Pharmaceutical Industries Ltd.June 11, 2019

FDA 483 - Sun Pharmaceutical Industries Ltd. - June 11, 2019

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Record Details

This FDA Form 483 details significant deficiencies at Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India, observed during a June 2019 inspection. The firm failed to follow procedures for sterile drug product manufacturing, maintain proper laboratory control documentation, adequately establish design plans for a medical device, and validate a critical assembly process. These issues indicate a lack of robust quality control and process validation.

Company: Sun Pharmaceutical Industries Ltd.
Inspection Date: June 11, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Rebecca E. Dombrowski
Kejun Cheng (other)
Monica C. Burgos Garcia
Farhana Khan (Food and Nutration Service )

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ID · 9a238e21-583d-4f1d-9584-916caa09a278