# FDA 483 - Miguelangelo J. Perez-Cruet, M.D., M.S. - August 25, 2023

Source: https://www.keypedia.com/records/483/miguelangelo-j-perez-cruet-md-ms/5776c2f0-52ff-45a0-be8b-6d546a007d96

> FDA 483 for Miguelangelo J. Perez-Cruet, M.D., M.S. on August 25, 2023. Product: other. 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: 2023-08-25
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Miguelangelo J Perez-Cruet, M.D., M.S. in Waterford Township, MI, revealed significant deficiencies in the conduct of a clinical investigation, Protocol LSS17001. The firm failed to obtain proper informed consent, ensure adequate principal investigator oversight, maintain accurate subject records, manage protocol deviations, and provide accurate information to the Institutional Review Board. These issues indicate a serious lack of adherence to regulations governing human subject protection and clinical trial conduct.

## Related Documents

- [483 - 2009-12-02](https://www.keypedia.com/records/483/miguelangelo-j-perez-cruet-md-ms/135ef7ea-5169-4735-8914-d90229d8bce8)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/jennifer-a-kemp/51aa8f2f-ba64-47d3-aa06-b4595b3d15c8)
- [investigator](https://www.keypedia.com/people/corrine-m-carter/69e1be8c-1cd9-48d9-a08e-bf49060b94d6)

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