The inspection closed with five observations
Pharma major Lupin announced recently the completion of a US FDA inspection carried out at its Pithampur Unit-3 (Indore) facility.
The inspection was a GMP inspection for the facility and also a Pre-Approval Inspection (PAI) for the company’s Tiotropium DPI ANDA. The inspection at the site was conducted between October 8, 2018 and October 18, 2018.
The inspection closed with five observations. These observations are procedural in nature.