Cipla receives six observations from FDA for Goa manufacturing facility

Cipla Ltd said that the US Food and Drug Administration (FDA) has concluded an inspection of the company’s manufacturing facility in Goa and has made six observations.

The FDA inspection was carried out from 16-26 August 2022. It is a follow-up to the American regulator’s inspection at the facility in September 2019 and the warning letter issued to Cipla in February 2020.

According to Cipla, the latest FDA observations have some references to the observations made by the regulator during the September 2019 inspection.

The Indian pharma company said that the FDA did not make any data integrity (DI) observations.

Cipla stated: “The Company will work closely with the USFDA and is committed to address these within the stipulated time.”