MUMBAI – India’s Claris Injectables Ltd. has been served five inspectional observations by the U.S. Food and Drug Administration for its Chacharvadi-based facility near Ahmedabad following an inspection between May 4 and 11.
The four-page report addressed to Claris Chairman Arjun Handa cites issues such as incomplete data in laboratory records derived from tests, examinations and assays necessary to assure compliance with established...