# FDA 483 - Michigan Center for Skin Care Research - May 24, 2011

Source: https://www.keypedia.com/records/483/michigan-center-for-skin-care-research/f0dc56c7-6169-4027-b5d1-e8bec8d2c74f

> FDA 483 for Michigan Center for Skin Care Research on May 24, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michigan Center for Skin Care Research
- Inspection Date: 2011-05-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected Michigan Center for Skin Care Research, a bioequivalence clinical facility in Clinton Township, MI, from May 18-24, 2011. The inspection revealed that an investigation was not conducted in accordance with the investigational plan. This included enrolling a subject who met exclusion criteria and publishing recruitment advertising without prior IRB approval.

## Related Documents

- [483 - 2011-05-31](https://www.keypedia.com/records/483/michigan-center-for-skin-care-research/dc6e1930-cff4-489f-b118-e7594bee8e4c)

## Related Officers

- [L'Oreal F. Walker](https://www.keypedia.com/people/loreal-f-walker/54e821e1-4646-499e-91f1-a6b37214cb7c)
- [investigator](https://www.keypedia.com/people/nancy-a-bellamy/6763cde9-25d6-41ce-b822-bcf1a222a0fd)

Company: https://www.keypedia.com/companies/michigan-center-for-skin-care-research/7550803e-3cfe-4c16-89c5-a6d766a061c4

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