# FDA 483 - Oakdale Precision Inc - December 06, 2018

Source: https://www.keypedia.com/records/483/oakdale-precision-inc/cf5fa398-0f15-44e3-b549-88a3b5f3ea82

> FDA 483 for Oakdale Precision Inc on December 06, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oakdale Precision Inc
- Inspection Date: 2018-12-06
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Oakdale Precision Inc, a contract manufacturer in Oakdale, MN, was cited with two observations during an FDA inspection. The firm failed to establish design control procedures for a wheeled stretcher and lacked written procedures for handling Medical Device Reporting (MDR) events. These issues indicate significant deficiencies in their quality system.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/joseph-d-gong/c1079a56-5f84-4e0d-9f76-9dc1187e588a)

Company: https://www.keypedia.com/companies/oakdale-precision-inc/ec19a51a-a362-49df-9e1e-d12ff6807230

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d