Generic drugmaker Lupin’s Pithampur Unit-2 manufacturing facility has been issued a Form-483 with 10 observations by the U.S. Food and Drug Administration on completion of an inspection.
The U.S. FDA had inspected facility, in Madhya Pradesh, from March 21-29. The inspection closed with issuance of a Form-483 with 10 observations. “We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest,” Lupin said on Thursday.
