FDA EIR - Solara Active Pharma Sciences Limited - July 05, 2019

An FDA Post-Approval and current Good Manufacturing Practice (cGMP) inspection was conducted at Solara Active Pharma Sciences Limited, an Active Pharmaceutical Ingredient (API) and Intermediate manufacturer, from July 1 to July 5, 2019. The inspection evaluated changes to manufacturing processes and overall cGMP compliance, adhering to frameworks like Compliance Programs 7356.002F and ICH-Q7 guidance. Although no formal FDA-483 was issued, several observations were verbally discussed with firm management. Key issues included a lack of Quality Assurance approval for inspection forms, poor maintenance of the material storage cooler, inadequate security oversight in the tank farm, and overhead structures requiring repair. Furthermore, an uncalibrated temperature sensor, unidentified equipment, and door gaps were noted. Significant deficiencies were also identified in the microbiology laboratory, such as the absence of differential pressure indicators, written procedures for sample collection, and proper identification for sample containers. The firm's procedure for reserve samples lacked clarity regarding collection frequency and testing requirements. Solara Active Pharma Sciences Limited's management committed to address all identified deficiencies and provide a formal written response to the USFDA within 15 working days. The inspection concluded with a "No Action Indicated" classification, reflecting the firm's commitment to resolve the observations.