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JAS Diagnostics/Drew Scientific, Inc., a manufacturer and repackager of in vitro diagnostic chemistry and hematology reagents, failed to comply with current good manufacturing practice requirements under 21 CFR Part 820. During an April 2022 inspection, the FDA identified critical quality system violations, including failure to adequately establish and implement complaint handling procedures to document, investigate, and evaluate complaints for Medical Device Reportable (MDR) events. The company's devices were determined to be adulterated due to non-conformity of manufacturing methods, facilities, and controls with FDA quality system regulations.