An FDA inspection of Intas Pharma’s facility in Ahmedabad, Gujarat revealed numerous violations in its aseptic manufacturing.
The facility had no standard operating procedure (SOP) for monitoring aseptic manufacturing and filling, and no records of what the quality unit found during aseptic manufacturing.
Intas also failed to properly validate the aseptic and sterilization process and testing methods were not all verified under actual conditions of use, the agency said.
The investigators also flagged problems with the air supply to the aseptic processing areas, noting the plant lacked proper equipment to control the air pressure.
In addition, equipment used in the manufacture, processing, packing or holding of drug products was “not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance,” the agency said.