# FDA 483 - Monica Bhatia, MD - January 31, 2019

Source: https://www.globalkeysolutions.net/records/483/monica-bhatia-md/7fdeaccd-a994-41aa-ba22-314094c5ba1c

> FDA 483 for Monica Bhatia, MD on January 31, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Monica Bhatia, MD
- Inspection Date: 2019-01-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: This FDA Form 483 was issued to Monica Bhatia, MD, a clinical investigator in New York, NY, following an inspection from January 28-31, 2019. The inspection revealed significant issues related to the conduct of clinical research, specifically concerning the timely reporting of study changes to the IRB and adherence to the investigational plan. These findings indicate a lack of adequate oversight and compliance with regulatory requirements for clinical trials, including proper dosing and timely reporting of serious adverse events.

## Related Officers

- [Joanne M. Schlossin](https://www.globalkeysolutions.net/people/joanne-m-schlossin/5cb48b8a-d885-4b4f-8c60-d4714d65603d)

Company: https://www.globalkeysolutions.net/companies/monica-bhatia-md/912aa282-b28e-4bf5-9875-e59b086b1e32

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