Gland Pharma gets 2 USFDA observations for Pashamylaram Facility
Telangana: Gland Pharma has announced that 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 the Company’s Pashamylaram Facility at Hyderabad from 23rd August, 2023 to 26th August, 2023.
The Company has received two observations on Form 483 with respect to ANDA filed for the product to be manufactured in a PEN device at the said Facility. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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