Issues five observations
Lupin announced 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 08 October 2018 and 18 October 2018.The inspection closed with five observations. These observations are procedural in nature.
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