United States Food and Drug Administration (USFDA) has concluded Good Manufacturing Practices (GMP) inspection of Piramal Pharma’s Morpeth, UK facility. The inspection was conducted from September 3, 2026 to September 11, 2026.
At the conclusion of the inspection, the USFDA issued a Form-483, with 7 observations. These observations are related to enhancement in the company’s practices, procedures and documentation.
The company is diligently addressing these observations and is preparing a detailed response for submission to the USFDA within the stipulated timeline. 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.
