Receives Form 483 with six observations
Piramal Pharma announced that the US FDA conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of Piramal Pharma's Lexington (Kentucky, USA) facility from 27 December 2022 to 10 January 2023.At the conclusion of the inspection, the US FDA issued a Form-483, with six observations. The observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity. The Company is preparing a detailed response to the observations, which will be submitted to the US FDA 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.
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