# FDA 483 - Mark R. Newton, M.D. - September 23, 2021

Source: https://www.globalkeysolutions.net/records/483/mark-r-newton-md/6a99e43f-98f9-4254-aad8-d2309a71a9f0

> FDA 483 for Mark R. Newton, M.D. on September 23, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark R. Newton, M.D.
- Inspection Date: 2021-09-23
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: This FDA Form 483 was issued to Mark R. Newton, M.D. in Waterloo, IA, following an inspection from September 20-23, 2021. The inspection revealed significant deficiencies in the conduct of an investigational study, including enrollment of subjects with exclusionary criteria, failure to obtain prior IRB/sponsor approval for protocol deviations, and inaccurate reporting to the IRB. These issues indicate a lack of adherence to investigational plans and regulatory requirements, potentially impacting subject safety and study validity.

## Related Documents

- [EIR - 2021-09-23](https://www.globalkeysolutions.net/records/eir/mark-r-newton-md/a47e3174-15b4-4574-9b60-f4e0b6849031)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)

Company: https://www.globalkeysolutions.net/companies/mark-r-newton-md/4d423034-05af-4f20-9051-6a67a4610ffb

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d