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

An FDA inspection conducted from April 24 to April 28, 2023, at K Patel Phyto Extractions Pvt Ltd, an Active Pharmaceutical Ingredient (API) manufacturer in District Valsad, Gujarat, India, identified significant issues related to quality control documentation and investigation processes. The observations were documented in an FDA Form 483 issued to Site Director Mr. Parimal A. Desai. The primary concern highlighted was that the firm's written records for investigating unexplained discrepancies lacked adequate explanations and conclusions. For instance, an Out of Specification (OOS) investigation (OOS/KP/RM/002/20) regarding a specific batch failed to identify a complete root cause. While it cited analyst error, it overlooked a critical omission within the standard testing procedure itself that contributed to the issue. Furthermore, approximately five Laboratory Incident Reports, filed between April and October 2020 concerning stability chamber temperature and humidity failures, were deficient as they did not specify the product names or batch numbers affected by these excursions. These observations indicate a need for improved robust investigation practices and comprehensive documentation to ensure product quality and compliance with regulatory expectations. The company is expected to thoroughly address these findings to demonstrate adherence to good manufacturing practices.