# FDA 483 - Orthocare Innovations, LLC - October 10, 2019

Source: https://www.keypedia.com/records/483/orthocare-innovations-llc/1f8087aa-5ed1-4f6d-a6ab-844bce861e99

> FDA 483 for Orthocare Innovations, LLC on October 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orthocare Innovations, LLC
- Inspection Date: 2019-10-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Orthocare Innovations, LLC in Edmonds, WA, conducted from October 8-10, 2019, identified two significant observations. The firm's purchasing procedures lacked a statistical rationale for raw material sampling during incoming inspection. Additionally, there were no written agreements with suppliers to ensure notification of product or service changes.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)

Company: https://www.keypedia.com/companies/orthocare-innovations-llc/32af70e1-5284-4980-ae70-bbbfd8ae83b6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822