# FDA 483 - Applied Neuroscience, Inc. - April 11, 2022

Source: https://www.keypedia.com/records/483/applied-neuroscience-inc/5475a15f-19e1-43aa-a5b6-119c034dc4d9

> FDA 483 for Applied Neuroscience, Inc. on April 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Applied Neuroscience, Inc.
- Inspection Date: 2022-04-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Applied Neuroscience, Inc. in St Petersburg, FL, a manufacturer of medical device software, was inspected by the FDA from April 4-11, 2022. The inspection revealed significant and repeat deficiencies across multiple critical quality system areas, including CAPA, complaint handling, design controls, document control, management review, quality audits, and training. The firm's quality system appears to be largely undeveloped or poorly implemented, indicating a high level of non-compliance.

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.keypedia.com/companies/applied-neuroscience-inc/affb23f7-fab7-47a3-94ec-6e38a9234678

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6