Drug major Cipla 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 (U.S. FDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6 – 17, the Mumbai-based drug firm said in a regulatory filing.
On conclusion of the inspection, the company has received 8 inspectional observations in Form 483, it added.
The company will work closely with the U.S. FDA and is committed to address these comprehensively within stipulated time, it said.
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