Piramal Pharma Limited announced the conclusion of a general Good Manufacturing Practices (GMP) inspection conducted by the US FDA at its Digwal, Telangana facility. The inspection took place from February 9 to February 13, 2026. The FDA issued a Form-483 citing 4 observations. The company confirmed that these observations relate to procedural enhancements only, are not related to data integrity, and will be classified as a Voluntary Action Indicated (VAI).
US FDA Inspection at Digwal Facility
Piramal Pharma Limited has formally informed the stock exchanges regarding the completion of an inspection by the United States Food and Drug Administration (US FDA) at its manufacturing facility located in Digwal, Telangana, India. The inspection period spanned from 9th February, 2026, to 13th February, 2026.
Form-483 Observations and Classification
At the final summation of the inspection process, the US FDA issued a Form-483 detailing 4 specific observations. Importantly, the Company stated that these observations are focused on the enhancement of procedures and do not involve data integrity issues. Furthermore, these findings are expected to be classified under the VAI (Voluntary Action Indicated) category.
Management Response and Commitment
Piramal Pharma Limited is actively engaged in preparing a comprehensive, detailed response addressing each of the observations noted in the Form-483. This submission will be made to the US FDA within the stipulated timelines. The management reiterated its ongoing commitment to maintaining the highest standards of compliance and assured stakeholders it will work closely with the agency to address all concerns effectively.
Source: BSE
