483
Glenmark Life Sciences LimitedGlenmark Life Sciences Limited – FDA 483, Jan 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.
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ID · 1b835108-bcc1-4085-954e-8612b345f7b7
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