483
Glenmark Life Sciences LimitedGlenmark Life Sciences Limited – FDA 483, Jul 5, 2019
Record Details
An FDA inspection of Glenmark Life Sciences Limited in Ankleshwar, India, revealed significant deficiencies across multiple areas. Observations included inadequate personnel training and record-keeping, incomplete batch production and control records, and deficient control systems to prevent contamination. Furthermore, the firm failed to conduct comprehensive investigations into product impurities, indicating a lack of robust quality control.
View Company Profile
ID · 50b7309f-a686-4319-896b-93444b555a0c
Other documents for Glenmark Life Sciences Limited
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.