FDA 483 - Synergene Active Ingredients Pvt. Ltd. (Unit II) - February 17, 2024

An FDA inspection of Synergene Active Ingredients Pvt Ltd, an Active Pharmaceutical Ingredient (API) manufacturer in Parawada, India, conducted from February 13-17, 2024, resulted in a Form FDA 483, identifying significant deficiencies in adherence to good manufacturing practices. The inspection noted three primary areas of concern. First, the firm's investigations into Out-of-Specification (OOS) results and Laboratory Incident Reports (LIRs) were deemed inadequate. Examples included attributing root causes like "pressure fluctuation" without sufficient evidence or subsequent corrective actions, and quality control staff reviewing only printed analytical results, overlooking electronic "Scan Halted" events for critical equipment like Infrared spectrometers. Second, issues were found with equipment cleaning and sanitation procedures. Residues from previous API manufacturing were observed on non-dedicated equipment, indicating ineffective cleaning. Furthermore, cleaning validation reports lacked crucial details such as surface area calculations for equipment, and corresponding raw data was unavailable, questioning the validity of cleaning verification methods. Finally, process documentation was incomplete. Batch Manufacturing Records for API production did not fully detail critical steps, such as specific volume measurements, or accurately describe the scope of certain process stages. Synergene Active Ingredients Pvt Ltd is now required to address these observations promptly with comprehensive corrective and preventive actions to ensure compliance with established quality and regulatory standards for API manufacturing.