By: IPP Bureau
Last updated : August 28, 2022 7:41 pm
There are no data integrity (DI) observations.
Further to United States Food and Drug Administration (USFDA) inspection at Cipla Ltd's Goa manufacturing facility in September 2019 and the warning letter received in February 2020, the Goa plant recently underwent a USFDA inspection from 16th - 26th August 2022.
On conclusion of the inspection, the company has now received 6 observations with some referencing to the observations made during the September 2019 inspection. There are no data integrity (DI) observations. The company will work closely with the USFDA and is committed to address these within the stipulated time.