Granules India Limited has announced that its subsidiary, Granules Pharmaceuticals, Inc. (GPI), successfully completed a routine cGMP audit conducted by the US Food and Drug Administration (FDA) at its Chantilly, Virginia facility. The inspection, which took place from March 30 to April 3, 2026, resulted in four Form 483 observations. The company emphasized that these findings pertain to procedural matters and do not involve data integrity issues.
Audit Overview and Results
Granules India Limited confirmed that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), has finalized a routine inspection by the US Food and Drug Administration (FDA). The audit, held at the company’s manufacturing plant in Chantilly, Virginia, was conducted over a period of five days, concluding on April 3, 2026.
Inspection Findings
During the process, the regulatory body issued four Form 483 observations. The company has clarified that these observations are limited to procedural matters. Significantly, no observations related to data integrity were reported, underscoring the company’s commitment to maintaining robust quality control systems.
Next Steps and Commitment
This event marks the second inspection of the Chantilly site within the past twelve months. Granules India remains focused on upholding the highest standards of safety, quality, and regulatory compliance. The company is currently working on a plan to address the observations raised by the US FDA and expects to resolve them within the stipulated timelines provided by the regulator.
Source: BSE
