FDA 483 - Amsino Healthcare (USA) Inc. - January 30, 2025

During a recent inspection conducted by the U.S. Food and Drug Administration (FDA) at a pharmaceutical manufacturing facility, several significant observations were noted, indicating deviations from current Good Manufacturing Practice (cGMP) regulations. Key issues identified include a lack of adequate procedures for investigating out-of-specification results and deviations, potentially impacting product quality and consistency. Inspectors also observed deficiencies in the environmental monitoring program within critical manufacturing areas, raising concerns about potential contamination risks. Furthermore, the firm's equipment maintenance and calibration programs were found to be insufficient, leading to questions about the reliability of manufacturing processes. Documentation practices were also highlighted as requiring improvement, with instances of incomplete or inaccurate records related to batch production and quality control. These findings necessitate prompt and comprehensive corrective actions. The inspected facility is required to conduct a thorough investigation into each observation, implement effective corrective and preventive actions (CAPA), and provide a detailed written response to the FDA outlining their plan to achieve and sustain compliance with cGMP standards, thereby ensuring product safety and quality.