Cipla says USFDA issued 7 observations after inspecting Bengaluru API unit
The United States Food and Drug Administration (USFDA) issued seven observations after conducting a routine cGMP inspection at Ciplas API manufacturing facility in Virgonangar, Bengaluru, the homegrown pharma major said Friday. The inspection was conducted from June 15 to June 19, Cipla said in a regulatory filing.
"The inspection ended with seven observations, none of which were repeat or related to data integrity," Cipla said.
The company will respond to the agency within the stipulated timeline, it added.