# FDA 483 - Okami Medical Inc. - December 04, 2024

Source: https://www.keypedia.com/records/483/okami-medical-inc/48a82f0a-c58c-4f9a-b969-c007e738b7c3

> FDA 483 for Okami Medical Inc. on December 04, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Okami Medical Inc.
- Inspection Date: 2024-12-04
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Okami Medical Inc. in Aliso Viejo, CA, was cited for significant deficiencies across its quality system during an FDA inspection. The inspection revealed issues with design validation, software validation, complaint handling, corrective and preventive actions, nonconforming product control, device history records, and document control. These observations indicate a systemic failure to adhere to established procedures and regulatory requirements for medical device manufacturing.

## Related Officers

- [Scott D. Stevens](https://www.keypedia.com/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/okami-medical-inc/d33c874f-ddfb-4794-9c0b-53c68a2c4366

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b