FDA 483 - Vasudha Pharma Chem Limited - March 14, 2025

During an inspection conducted by the U.S. Food and Drug Administration from March 10 to March 14, 2025, Vasudha Pharma Chem Limited, Unit-I, an Active Pharmaceutical Ingredient manufacturer in Jeedimetla, India, received a Form FDA 483 citing significant issues with its manufacturing and quality control practices. The inspection revealed a critical failure to thoroughly investigate out-of-specification results and deviations in process parameters, with insufficient scientific justification for root causes and inadequate corrective actions. Specifically, investigations for impurities, residual solvents, and critical pH deviations lacked proper assessment of impact on product quality or sufficient documentation. Furthermore, the facility demonstrated deficiencies in equipment cleaning and maintenance. Residue was observed on equipment labeled "cleaned," and equipment usage logbooks showed inconsistencies. Cleaning validation studies, including dirty hold times and campaign cleaning effectiveness, were incomplete or lacked adequate sampling to verify residue removal. Equipment qualification was also found to be deficient, with records missing crucial information such as material loaded during processes, impacting assurance of product uniformity. Additionally, cleaning procedures for specific equipment were deemed inadequate, lacking detailed instructions for disassembly and cleaning of all parts. Water sampling plans for microbiological analysis were criticized for not accurately representing actual manufacturing conditions, thus failing to ensure the quality of water used in production. These observations highlight a need for Vasudha Pharma Chem Limited to enhance its quality management system, revise procedures, and implement robust corrective actions to ensure product quality and compliance with regulatory expectations for pharmaceutical manufacturing.