Granules India Limited has announced the completion of a routine current Good Manufacturing Practices (cGMP) audit by the US Food and Drug Administration (FDA) at its Chantilly, Virginia site. The audit, conducted from March 30 to April 3, 2026, resulted in four Form 483 observations.
This marks the second US FDA inspection at the Chantilly facility within the last year. The observations noted were related to procedural matters, with no data integrity issues reported during the inspection.
Granules India has expressed its commitment to maintaining high standards of quality, safety, and regulatory compliance. The company has stated that it will address the observations raised by the US FDA within the stipulated timelines.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).