# FDA 483 - Monica M. Mita, MD, MSc, Clinical Investigator - October 24, 2016

Source: https://www.keypedia.com/records/483/monica-m-mita-md-msc-clinical-investigator/44a0eef3-57ac-454b-aa2e-2d708349bd21

> FDA 483 for Monica M. Mita, MD, MSc, Clinical Investigator on October 24, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Monica M. Mita, MD, MSc, Clinical Investigator
- Inspection Date: 2016-10-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Monica M. Mita, M.D., a clinical investigator in Los Angeles, revealed significant deviations from investigational plans and regulatory requirements. Observations included failure to follow the study protocol for subject dosing, inadequate and inaccurate case histories with unreported adverse events and concomitant medications, and issues with informed consent documentation. These findings indicate a lack of adherence to good clinical practice.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/diane-c-van-leeuwen/98af0d70-2db1-4132-8193-fcccf8841960)

Company: https://www.keypedia.com/companies/monica-m-mita-md-msc-clinical-investigator/2bd72b57-d56d-4e4d-83ac-a7821a5e407c

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