# FDA 483 - VHA Office of Advanced Manufacturing - Ft Lawton - January 23, 2025

Source: https://www.keypedia.com/records/483/vha-office-of-advanced-manufacturing-ft-lawton/9e83f1e0-793a-4e96-8450-85fb27515554

> FDA 483 for VHA Office of Advanced Manufacturing - Ft Lawton on January 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VHA Office of Advanced Manufacturing - Ft Lawton
- Inspection Date: 2025-01-23
- Product Type: device
- Office Name: Seattle District Office
- Summary: VHA Office of Advanced Manufacturing - Ft. Lawton, a manufacturer of medical devices including the Class II VHA Radiotherapy Bolus, was inspected and cited for significant quality system deficiencies. Observations included inadequate documentation of corrective and preventive actions, failures in complaint handling procedures, and insufficient supplier and internal quality audit processes. These issues indicate a lack of adherence to established quality system requirements and internal procedures.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/vha-office-of-advanced-manufacturing-ft-lawton/33242517-6e04-43de-a9ea-b70cc6703b8a

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913