U.S. FDA issues two observations to Cipla arm InvaGen’s U.S. facility

The U.S. Food and Drug Administration (U.S. FDA) has issued two observations to Cipla’s U.S. subsidiary, InvaGen Pharmaceuticals, regarding its Long Island manufacturing facility.

The observations followed a pre-approval inspection (PAI) by the regulator at InvaGen’s manufacturing facility in Hauppauge, Long Island, New York, from February 2 to 9.

“On conclusion of the inspection, InvaGen received two inspectional observations in Form 483. The company will work closely with the U.S. FDA and is committed to address these comprehensively within stipulated time,” Cipla said in a filing on Tuesday (February 10, 2026).