Glenmark issued FDA Form 483 for Monroe formulation manufacturing facility
Glenmark Pharmaceuticals said that it has been issued Form 483 with 17 observations by the US Food and Drug Administration (FDA) following an inspection at its formulation manufacturing facility in Monroe, North Carolina.
The FDA inspection was carried out between 4 April 2022 and 19 May 2022.
Glenmark Pharmaceuticals said that it voluntarily recalled all its products from the Monroe formulation manufacturing facility in August 2021. Since that time, the Indian pharma company has not been commercializing any product from the facility.
In a statement, Glenmark Pharmaceuticals, said: “The Company will continue to work with the U.S. FDA and is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe.”