FDA 483 - Landauer - March 16, 2023

Landauer, a manufacturer of radiation dosimetry devices in Glenwood, IL, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to investigate a patient overexposure event and did not submit a required MDR report, alongside lacking established procedures for design control, process validation, corrective and preventive actions, supplier control, statistical techniques, management review, rework, and internal quality audits. These observations indicate a broad failure to implement and maintain a compliant quality system.