# FDA 483 - Miguelangelo J. Perez-Cruet, M.D., M.S. - December 02, 2009

Source: https://www.keypedia.com/records/483/miguelangelo-j-perez-cruet-md-ms/135ef7ea-5169-4735-8914-d90229d8bce8

> FDA 483 for Miguelangelo J. Perez-Cruet, M.D., M.S. on December 02, 2009. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miguelangelo J. Perez-Cruet, M.D., M.S.
- Inspection Date: 2009-12-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: This FDA Form 483 report details significant deficiencies at Miguelangelo J. Perez-Cruet, M.D., M.S., a clinical investigator in Royal Oak, MI. The inspection revealed widespread issues across multiple studies, including failures in obtaining proper informed consent, inadequate reporting of adverse device effects, and non-compliance with financial disclosure requirements. The firm also failed to conduct investigations according to agreements and protocols, maintained inaccurate and incomplete subject records, and conducted a treatment use study without full IRB approval.

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- [483 - 2023-08-25](https://www.keypedia.com/records/483/miguelangelo-j-perez-cruet-md-ms/5776c2f0-52ff-45a0-be8b-6d546a007d96)

## Related Officers

- [Investigator](https://www.keypedia.com/people/barbara-a-rusin/b5b602ee-bef9-4103-bb91-8b37d42ae5bd)

Company: https://www.keypedia.com/companies/miguelangelo-j-perez-cruet-md-ms/119beb66-307e-4156-a2f4-e7eddbb68913

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0