483
Gland Pharma Limited, Units I+II Pashamylaram SiteGland Pharma Limited, Units I+II Pashamylaram Site – FDA 483, Aug 26, 2023
Record Details
Gland Pharma Limited in Hyderabad, India, a device manufacturer, was inspected by the FDA from August 23-26, 2023. The inspection revealed two significant issues: inadequate qualification of manufacturing equipment for Liraglutide Injection devices and failures in maintaining quality system records. These observations indicate deficiencies in both equipment validation and data management practices, including improper computer access.
- Inspection date
- August 26, 2023
- Product type
- device
View Company Profile
ID · c2f4d2bb-1f08-4cc0-b659-19378e201a83
Other documents for Gland Pharma Limited, Units I+II Pashamylaram Site
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.