Cipla’s Pithampur unit gets 8 observations from US FDA after inspection – ET HealthWorld


Cipla's Pithampur unit gets 8 observations from US FDA after inspection

New Delhi: 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.

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