# FDA 483 - Michael T. Lin, M.D. - July 15, 2022

Source: https://www.keypedia.com/records/483/michael-t-lin-md/cf90a592-55c4-4905-8cfb-d91d453cb135

> FDA 483 for Michael T. Lin, M.D. on July 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael T. Lin, M.D.
- Inspection Date: 2022-07-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Michael T. Lin, M.D., a clinical investigator in New York, NY, revealed a significant violation related to human subject protection. The firm failed to obtain informed consent from a human subject prior to administering a study drug and conducting related tests, as required by protocol and federal regulations. This indicates a serious lapse in ethical and regulatory compliance for clinical trials.

## Related Officers

- [Omadevi Somai](https://www.keypedia.com/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)

Company: https://www.keypedia.com/companies/michael-t-lin-md/6051da9e-5438-4803-a467-0352ece7f1e0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961
