FDA 483 - Kreative Organics Private Limited - May 02, 2025

Kreative Organics Private Limited in Hyderabad, India, an API manufacturer, was cited for three significant issues during an FDA inspection. Observations included deficiencies in water suitability testing for API manufacturing, inadequate validation of cleaning methods for API equipment, and a failure to follow product recall procedures when a commercial batch failed long-term stability testing, including not notifying regulatory authorities. These issues indicate serious concerns regarding quality control and product safety.