483
Glenmark Life Sciences LimitedFDA 483 - Glenmark Life Sciences Limited - January 27, 2025
Record Details
Granules Life Sciences Limited, an API manufacturer in Ankleshwar, Gujarat, was cited for failing to prevent contamination during production operations. Inspectors observed magnetic metal fragments in equipment after cleaning hold times expired, and the firm had received multiple market complaints regarding metal foreign material. This indicates a significant issue with contamination control and equipment cleaning procedures.
Open in Dashboard
ID · 1b835108-bcc1-4085-954e-8612b345f7b7