U.S. FDA issues three observations to Gland Pharma’s Vizag unit 

Generic injectable-focused Gland Pharma facility in Visakhapatnam has been issued three observations by the U.S. Food and Drug Administration (U.S. FDA).

“The U.S. FDA conducted a pre-approval inspection (PAI) for sterile active pharmaceutical ingredients (APIs) at the company’s facility in JNPC, Visakhapatnam from February 19-25. The inspection concluded with three Form 483 observations,” Gland Pharma said in a filing on Tuesday.

The observations are procedural in nature and the corrective and preventive actions will be submitted to the agency within the stipulated period. The observations issued are neither repeat observations nor related to data integrity, the company said.