# FDA 483 - Morgan Newton Comp. - February 11, 2020

Source: https://www.globalkeysolutions.net/records/483/morgan-newton-comp/d3771cd2-c989-4121-9d91-d0237a72e5a8

> FDA 483 for Morgan Newton Comp. on February 11, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Morgan Newton Comp.
- Inspection Date: 2020-02-11
- Product Type: device
- Office Name: Dallas District Office
- Summary: Morgan Newton Company, a medical device manufacturer in Plano, TX, was inspected by the FDA and cited for multiple quality system deficiencies. The inspection revealed a lack of documented procedures for production, incomplete documentation of acceptance test results, and inadequate control over product acceptance status and document changes. Additionally, the firm failed to validate equipment, properly implement corrective and preventive action procedures, and document maintenance activities, indicating significant gaps in their quality management system.

## Related Documents

- [483 - 2023-05-12](https://www.globalkeysolutions.net/records/483/morgan-newton-comp/02cc7681-1e2d-4c87-8466-70149a14509f)
- [483 - 2025-05-29](https://www.globalkeysolutions.net/records/483/morgan-newton-comp/c2facf03-701a-4b6a-ba31-189fe1131f5c)

## Related Officers

- [Jennifer Cunningham](https://www.globalkeysolutions.net/people/jennifer-cunningham/5c332d60-b1e8-444f-8994-68cb1586c7eb)

Company: https://www.globalkeysolutions.net/companies/morgan-newton-comp/6944980a-e15f-4d2e-9a6a-e141f444bf70

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9