Gland Pharma announced that following the Pre-Market Inspection covering US FDA's Quality System/Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820) at the Company's Dundigal Facility at Hyderabad from 22 August 2022 to 25 August 2022; the Company has received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, US FDA indicating closure of the inspection.
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