New Delhi: Drug major Cipla said the US health regulator has conducted an audit at its Indore facility and has not issued any data integrity or repeat observations.
“The United States Food and Drug Administration (USFDA) conducted a routine current Good Manufacturing Practices (cGMP) audit at its Indore formulations facility from April 2, 2018, till April 13, 2018,” Cipla said in a BSE filing.
There were no data integrity and/or repeat observations, it added.
The company, however, did not provide the details of observations it has received.
“At this stage, the company believes the observations are unlikely to have any material adverse impact. The Company will submit the response within the stipulated time frame,” Cipla said.