Cipla says Indore plant received observations, no data integrity issues
Cipla has clarified that the USFDA conducted a routine cGMP audit at its Indore formulations facility from 2-13 April 2018. According to Cipla, this was a normal course of business. At the end of the inspection, USFDA has issued form 483 observations. The company has also said that there were no data integrity and/or repeat observations. We had reported of USFDA inspection at Indore on April 05, 2018.
The company believes that the observations are unlikely to have any material adverse impact and will submit the response within the stipulated time frame.
Indore is a formulations manufacturing facility. The Indore SEZ facility had received nine USFDA observations in 2015 and was cleared in 2016. As per one of the earlier management comments, Indore is not a very significant plant at the moment as it is a newer plant.