# FDA 483 - Osprey Medical Inc - May 24, 2019

Source: https://www.keypedia.com/records/483/osprey-medical-inc/75dc8947-f359-4237-939b-8651f2f2b014

> FDA 483 for Osprey Medical Inc on May 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Osprey Medical Inc
- Inspection Date: 2019-05-24
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Osprey Medical Inc. in Hopkins, MN, was inspected from May 22-24, 2019. The inspection revealed that the firm failed to adequately validate its packaging processes for finished DyeVert devices. This finding indicates a significant deficiency in process control and validation procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

Company: https://www.keypedia.com/companies/osprey-medical-inc/d86f787f-b511-47a0-b54d-fb69a6974735

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