The US Food and Drug Administration (US FDA) conducted its pre-market inspection covering quality system/current good manufacturing practice (cGMP) regulations for medical devices at Gland Pharma's Dundigal facility in Hyderabad.

The US drug regulator inspected the facility from August 22, 2022 to August 25, 2022. On August 26, 2022, the company received one observation on Form 483 for ANDA filed for the product to be manufactured at the said facility. There was no data integrity observation.

The pharma company said that it has now received an Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, US FDA indicating the closure of the inspection.

Hyderabad-based Gland Pharma has grown over the years from a contract manufacturer of small-volume liquid parenteral products, to become one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.