The Office of Medical Device and Radiological Health Operations (OMDRHO), United States Food and Drug Administration (US FDA) conducted Pre-Market Inspection covering US FDA's Quality System/Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820) at Gland Pharma Ltd's Dundigal Facility at Hyderabad from 22nd August, 2022 to 25th August, 2022.

The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility. There is no data integrity observation.

The company is committed to address the observation and will submit its response to US FDA within the stipulated time.