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.

There is no data integrity observation.

"The Company is committed to address the observations and will submit its response to US FDA within the stipulated time," the company stated in a BSE filing.

Medical Dialogues team had earlier reported that the USFDA had concluded the inspection at the company's Pashamylaram Facility with one 483 Observation. 

Read also: Gland Pharma gets one USFDA observation for Pashamylaram Facility

Gland Pharma, a generic injectable-focused pharmaceutical company, was established in 1978 in Hyderabad. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.

Read also: Gland Pharma reports 41 percent jump in Q1 revenue