USFDA gives 5 observations to Glenmark Pharma for Goa facility
Drugmaker, Glenmark Pharma, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with five observations after an inspection at the Company’s formulation manufacturing facility based out of Goa, India.
The inspection was conducted between May 12, 2022 and May 20, 2022.”This is to inform you that the USFDA has issued Form 483 with five observations after an inspection at the Company’s formulation manufacturing facility based out of Goa, India between May 12, 2022 and May 20, 2022,” the company stated in a BSE filing.
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.
“The company is committed to undertake all necessary steps required to address their observations at the earliest.
The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe,” Glenmark added.
Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries.
Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology.