Drug major Cipla on Saturday said the US health regulator has issued Form 483 with eight observations after inspecting its Pithampur-based manufacturing facility in Madhya Pradesh.
The US Food and Drug Administration (USFDA) 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 USFDA and is committed to address these comprehensively within stipulated time, it said.
(With inputs from health)