# FDA 483 - Perahealth Inc - January 30, 2020

Source: https://www.globalkeysolutions.net/records/483/perahealth-inc/bb738ff6-743b-4920-a13a-82642e2ab0fd

> FDA 483 for Perahealth Inc on January 30, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perahealth Inc
- Inspection Date: 2020-01-30
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Perahealth Inc, a medical device software manufacturer in Charlotte, NC, was inspected by the FDA, resulting in 14 observations. The inspection revealed significant deficiencies across its quality system, including a lack of design plans, inadequate design validation documentation, missing MDR procedures, and widespread issues with document control, training, and management review processes. These findings indicate a fundamental lack of established and maintained quality system procedures.

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/perahealth-inc/eabf9030-a82f-4848-9801-1d215c28cde1

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7