# FDA 483 - Michigan Center for Skin Care Research - May 31, 2011

Source: https://www.keypedia.com/records/483/michigan-center-for-skin-care-research/dc6e1930-cff4-489f-b118-e7594bee8e4c

> FDA 483 for Michigan Center for Skin Care Research on May 31, 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: 2011-05-31
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Michigan Center for Skin Care Research, a bioequivalence clinical facility, identified two observations. The firm was cited for making promotional representations on its website regarding the safety and effectiveness of investigational drugs and for offering benefits to participants. Additionally, the firm failed to ensure that an Institutional Review Board (IRB) was responsible for the initial and continuing review and approval of clinical studies, specifically regarding recruitment advertisements placed online without IRB approval.

## Related Documents

- [483 - 2011-05-24](https://www.keypedia.com/records/483/michigan-center-for-skin-care-research/f0dc56c7-6169-4027-b5d1-e8bec8d2c74f)

## 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