Glenmark Pharma’s North Carolina facility gets five U.S. FDA observations 

The U.S. Food and Drug Administration (FDA) has issued a Form 483 with five observations to Glenmark Pharmaceuticals’ manufacturing facility in Monroe, North Carolina, U.S.

The observations were issued at the end of GMP inspection of facility from June 9-17, the company said in a filing on Wednesday. All the observations are procedural in nature and not related to data integrity. The company said it will work in close collaboration with the regulator to address them and respond to within the stipulated timeline.