The United States Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at Piramal Pharma’s Lexington (Kentucky, USA) facility from December 27, 2022 to January 10, 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 does 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.
Piramal Pharma (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 15 global facilities and a global distribution network in over 100 countries.
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