483
Gland Pharma LimitedGland Pharma Limited – FDA 483, Jul 25, 2024
Record Details
An FDA inspection of Gland Pharma Limited, a human drug manufacturer in Hyderabad, India, from July 22-25, 2024, revealed significant deficiencies. The firm failed to adequately follow and document quality control procedures for monitoring non-viable particle count excursions. Additionally, critical production and control records, specifically CCTV footage of aseptic operations, were not retained for the required duration.
View Company Profile
ID · a1d0389a-8f1b-419e-aa72-90e50dbc4369
Other documents for Gland Pharma 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.