Piramal Pharma Limited has informed that USFDA has conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited's Lexington (Kentucky, USA) facility from 27th December 2022 to 10th January, 2023.

At the conclusion of the inspection, the USFDA issued a Form-483, with six observations. The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity.

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the 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.