Piramal Pharma's UK Facility Receives 7 USFDA Observations
Mumbai: The US Food and Drug Administration (USFDA) has issued seven observations following a Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited's Morpeth, UK facility.
The inspection was conducted from September 3 to September 11, 2026.
At the conclusion of the inspection, the US FDA issued a Form-483 containing seven observations. The observations are related to enhancement of the company’s practices, procedures and documentation.
Piramal Pharma stated that it is diligently addressing the observations and is preparing a detailed response for submission to the US FDA within the stipulated timeline. The company also stated that it remains committed to maintaining the highest standards of compliance and will work closely with the regulatory agency to comprehensively address all the observations.
The inspection was conducted at Piramal Pharma’s Morpeth facility in the United Kingdom over the period of September 3 to September 11, 2026. The seven observations were issued at the completion of the GMP inspection.
Piramal Pharma Limited is a pharmaceutical company headquartered in Mumbai and is part of the Piramal Group. The company operates across pharmaceutical segments and has a global presence, with manufacturing and business operations serving domestic as well as international markets.
The company’s operations include complex hospital generics, India consumer healthcare and contract development and manufacturing services (CDMO). Its pharmaceutical business focuses on developing and manufacturing products across different therapeutic and healthcare segments, while its CDMO operations provide development and manufacturing capabilities for pharmaceutical companies.
Piramal Pharma also operates manufacturing facilities in India and overseas, including its Morpeth facility in the United Kingdom. The company serves regulated markets and maintains quality and compliance systems across its manufacturing network.
The company has stated that the observations identified during the latest inspection are being addressed and that a detailed response will be submitted to the US FDA within the prescribed timeline. It further stated that it will work closely with the agency to comprehensively address the observations.
