FDA 483 - Abhilasha Pharma Private Ltd - February 03, 2025

Abhilasha Pharma Pvt. Ltd. in Ankleshwar, India, an API manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate investigations of market complaints and deviations, insufficient cleaning validation for sterile API manufacturing equipment, and a lack of scientifically sound laboratory testing procedures for critical components and APIs. These issues indicate a serious lack of control over product quality and potential risks to sterile drug products distributed to the US.