Granules India Limited announced that its Gagillapur, Hyderabad facility has completed a United States Food and Drug Administration (USFDA) inspection. The inspection, conducted from October 19 to October 30, 2026, resulted in eleven observations. The company stated that none of the observations relate to data integrity or cross-contamination and impact on manufacturing or distribution is not anticipated. Granules will submit a comprehensive response within 15 business days.
USFDA Inspection at Gagillapur Facility
Granules India Limited has announced the conclusion of a routine Good Manufacturing Practice (GMP) inspection of its finished dosage facility located in Gagillapur, Hyderabad, by the United States Food and Drug Administration (USFDA). The inspection took place from October 19 to October 30, 2026, and resulted in the issuance of a Form FDA 483 detailing eleven observations.
Observations and Company Response
Significantly, Granules India clarified that none of the observations pertained to data integrity or cross-contamination. The reported observations are primarily related to areas such as enhancements in investigations, change control procedures, process and equipment qualification, visual-inspection controls, and documentation practices. The company emphasized that there is no impact on the manufacturing or distribution of products from the Gagillapur site. Granules is committed to submitting a comprehensive response to the USFDA within the stipulated 15 business days.
Context and Management Commentary
This inspection marks the first USFDA inspection of the facility since a Warning Letter was issued on February 26, 2025, following an inspection in August-September 2024. Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, commented, “The inspection progressed constructively, and the observations are of a nature that we believe can be fully addressed through our responses and corrective and preventive actions. Quality is the foundation of everything we do at Granules, and we will continue to engage transparently with the agency.”
Source: BSE
