Piramal Pharma Limited announced that the US FDA conducted a Good Manufacturing Practices (GMP) inspection at its Morpeth, UK facility from September 3rd to 11th, 2026. The inspection concluded with the issuance of a Form-483, noting 7 observations related to practices, procedures, and documentation. The company is actively addressing these points and preparing a detailed response for the FDA.
Piramal Pharma Faces FDA Scrutiny at UK Facility
Piramal Pharma Limited has disclosed that the U.S. Food and Drug Administration (FDA) conducted a routine inspection of its manufacturing facility located in Morpeth, UK. The inspection focused on Good Manufacturing Practices (GMP) and took place from September 3rd, 2026, through September 11th, 2026.
Observations and Response Plan
Upon completion of the inspection, the US FDA issued a Form-483, which documented seven observations. These observations are primarily related to enhancements needed in the company’s existing practices, procedures, and documentation. Piramal Pharma Limited has stated that it is diligently working to address these observations and is preparing a comprehensive response to be submitted to the US FDA within the mandated timeline.
Commitment to Compliance
The company reaffirmed its commitment to maintaining the highest standards of compliance and intends to work closely with the agency to comprehensively address all the points raised. This disclosure is for informational purposes and serves to update stakeholders on the regulatory status of the UK facility.
Source: BSE
