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.
The Company is preparing a detailed response to said observations, which will be submitted to the US FDA within stipulated timelines.
Piramal Pharma said, "The Company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations."
