FDA 483 - K Patel Phyto Extractions Private Ltd - April 28, 2023

An FDA inspection of K Patel Phyto Extractions Pvt Ltd, an API (Intermediate) Manufacturer, identified deficiencies in the firm's investigation processes. The observations highlight inadequate root cause analysis for Out of Specification (OOS) results and incomplete documentation for laboratory incident reports. These issues indicate a lack of thoroughness in addressing unexplained discrepancies and their potential impact.