Cipla's Pithampur Unit Gets Eight Observations From U.S. FDA

Drug major Cipla Ltd. on Saturday said the U.S. health regulator has issued Form 483 with eight observations after inspecting its Pithampur-based manufacturing facility in Madhya Pradesh.

The U.S. Food and Drug Administration conducted a current Good Manufacturing Practices inspection at the manufacturing facility from Feb. 6-17, the Mumbai-based drug firm said in a regulatory filing.

On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it said.

The company will work closely with the U.S. FDA and is committed to address these comprehensively within stipulated time, it said.