FDA Warns India’s Granules Generic Drug Company

FDA has sent a Warning Letter to Granules about its finished dosages and pharmaceutical formulation intermediates manufacturing facility in Gagillapur, near Hyderabad, India. The Hindu reports that the Warning Letter follows an 8/29-9/6/2024 agency inspection that resulted in six observations on a form FDA-483.

The Hindu says FDA classified the inspection as Official Action Indicated and that the company had paused its operations in 9/2024 to undertake a thorough risk assessment to ensure against product contaminant or patient safety concerns. It has since resumed operations.

Granules told the news agency that it has been working with three independent consulting firms with expertise in quality, compliance, and regulatory practices to assess and validate the effectiveness of its remediation efforts. It indicated it would seek a meeting with FDA to demonstrate its progress toward compliance.