QBTech Inc. – FDA 483, May 23, 2024

An FDA inspection of medical device manufacturer QBTech Inc., conducted from May 6 to May 23, 2024, revealed multiple observations indicating deficiencies in their quality system and adherence to regulatory requirements under the Federal Food, Drug, and Cosmetic Act. Key violations included a failure to adequately justify or record a field correction for QbTest PC/Laptops affected by a software bug, with critical recall documentation missing from the corrective action file.

The firm also failed to ensure Unique Device Identifiers (UDI) were present on medical device labels and that UDI procedures were comprehensive. Further observations highlighted an inadequately maintained Device Master Record for the QbTest, lacking essential device identification details and up-to-date component instructions. Process control procedures for converting laptops were not current, and software utilized for managing customer feedback and complaints within the quality system remained unvalidated. Additionally, complaint handling procedures were found to be deficient in documentation and traceability. The company's records of acceptable suppliers were incomplete, and document change control lacked detailed revision descriptions. QBTech Inc. is required to address these systemic issues, implement robust corrective actions, and ensure full compliance with FDA regulations for medical device manufacturing.