# FDA 483 - Mehran Michael Bahrami, M.D. - April 19, 2024

Source: https://www.keypedia.com/records/483/mehran-michael-bahrami-md/82e9d4ad-347a-4cc9-84e2-d47eb75702dd

> FDA 483 for Mehran Michael Bahrami, M.D. on April 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mehran Michael Bahrami, M.D.
- Inspection Date: 2024-04-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA issued a Form 483 to Mehran Michael Bahrami, M.D., following an inspection that revealed significant deficiencies in the conduct of clinical investigations. Key issues included failure to obtain informed consent, inadequate oversight of study procedures leading to protocol deviations, and poor record-keeping practices. These findings indicate a lack of adherence to regulatory requirements for human subject protection and data integrity in clinical trials.

## Related Officers

- [Chantae D. Mitchell](https://www.keypedia.com/people/chantae-d-mitchell/0da68244-86f3-4119-b965-0b2dceb1c523)
- [investigator](https://www.keypedia.com/people/ana-p-barido/4af1fa64-245e-4470-bd4b-975681d10a77)

Company: https://www.keypedia.com/companies/mehran-michael-bahrami-md/a10b2a3b-8f42-47d0-820c-4547db899b30

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