# FDA 483 - Landauer - March 16, 2023

Source: https://www.keypedia.com/records/483/landauer/d35c7057-764b-4f27-9152-96e714cf9541

> FDA 483 for Landauer on March 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Landauer
- Inspection Date: 2023-03-16
- Product Type: device
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [Brittani N. Franklin](https://www.keypedia.com/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

Company: https://www.keypedia.com/companies/landauer/bc8a9cbe-b778-4a26-8a93-11a259d9b715

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669