Glenmark Pharma gets 5 observations from USFDA for its Goa, India facility and 17 observations from USFDA for its Monroe, North Carolina facility.

The U.S. FDA has issued Form 483 with five observations after an inspection at Glenmark Pharmaceuticals Limited's formulation manufacturing facility based out of Goa, India between May 12, 2022 and May 20, 2022.

In a statement released to the exchanges, the company said that it 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. 

Secondly, the USFDA has issued Form 483 with 17 observations after an inspection at Glenmark Pharmaceuticals formulation manufacturing facility based out of Monroe, North Carolina, between April 04, 2022, and May 19, 2022.

The company had done a voluntary recall of all its products from this site in August 2021 and since then has not been commercializing any product from this site