FDA 483 - ALBA Bioscience Limited - March 17, 2023

ALBA Bioscience Limited, a manufacturer of Biologic IVDs in Penicuik, United Kingdom, was cited for significant deficiencies during an FDA inspection. Observations included inadequate Medical Device Reporting (MDR) procedures and failure to submit MDRs for device malfunctions, as well as an inadequate risk analysis for product issues like leaking vials. Additionally, the firm lacked adequate procedures for controlling labeling activities, leading to undefaced labels in trash.