Event Summary
The US Food and Drug Administration (US FDA) conducted a Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited's manufacturing facility located in Morpeth, UK [United Kingdom]. The inspection period was from 3rd September, 2026 to 11th September, 2026.
At the conclusion of the inspection, the US FDA issued a Form-483 containing 7 observations. The observations are related to enhancements required in the company's practices, procedures, and documentation.
Company Response and Commitment
The company states it is "diligently addressing these observations" and is preparing a detailed response for submission to the US FDA within the stipulated timeline provided by the agency. Piramal Pharma Limited reaffirms its commitment to "maintain the highest standards of compliance" and indicates it will "work closely with the agency to comprehensively address all the observations."
Additional Information
The disclosure was signed by Maneesh Sharma, Company Secretary & Compliance Officer of Piramal Pharma Limited, on 14th September, 2026 at 19:34:32 IST.