FDA 483 - Gland Pharma Limited, Units I+II Pashamylaram Site - August 26, 2023

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.