FDA 483 - QBTech Inc. - May 23, 2024

QBTech Inc., a medical device manufacturer in Houston, TX, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate recall documentation, UDI non-compliance, issues with device master records, and unvalidated software. These findings indicate a need for comprehensive improvements in the firm's quality management system.