# FDA 483 - Michelle Sato, M.D. - August 13, 2021

Source: https://www.keypedia.com/records/483/michelle-sato-md/7467947e-d386-4c26-bc5d-ad5b47a5eb9b

> FDA 483 for Michelle Sato, M.D. on August 13, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michelle Sato, M.D.
- Inspection Date: 2021-08-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Michelle Sato, M.D. in Los Angeles, CA, a clinical investigator, revealed significant deficiencies in the conduct of an investigational plan. The firm failed to report all adverse events and lacked adequate oversight of study staff, who made unauthorized changes to study logs and examinations. These findings indicate serious non-compliance with clinical trial regulations.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.keypedia.com/companies/michelle-sato-md/6b439c3c-fcb2-4d11-aa37-6c54e8100ae2

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6