By: IPP Bureau
Last updated : August 28, 2023 11:45 am
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
Gland Pharma Limited has announced that the Office of Medical Device and Radiological Health Operations (OMDRHO), United States Food and Drug Administration (USFDA) conducted Pre-Market Inspection covering USFDA'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 2 (TWO) observations on Form 483 with respect to ANDA filed for the product to be manufactured in a PEN device at the said Facility. 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.