FDA 483 - Octapharma Plasma, Inc. - March 22, 2024

An FDA inspection of Octapharma Plasma, Inc. in Dallas, TX, a source plasma center, revealed a significant quality control issue related to equipment calibration. The firm failed to ensure that weights used for plasma collection were calibrated against the proper weight standard, leading to an inability to determine equipment tolerance for critical devices. This lapse indicates a failure to comply with official requirements for equipment performance.