US FDA conducted a Pre-Approval Inspection (PAI) inspection of Piramal Pharma Limited's Lexington (USA) facility from 20 th February, 2024 to 23rd February, 2024 for one of the product expected to be manufactured at this facility.
On conclusion of the inspection, a Form-483 was issued with 2 observations. The observations does not pose any risk to site’s compliance standards or its business continuity.