United States Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection (PAI) inspection at Piramal Pharma’s Lexington (USA) facility from February 20, 2024 to February 23, 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 do 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 USFDA within stipulated timelines. The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.
Piramal Pharma provides end-to-end pharma services to customers and a portfolio of differentiated pharma products across a domestic and global distribution network.
