# FDA 483 - Sant P. Chawla, MD - April 15, 2022

Source: https://www.globalkeysolutions.net/records/483/sant-p-chawla-md/0a32a8a1-6d5e-481b-917d-19be4066a625

> FDA 483 for Sant P. Chawla, MD on April 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sant P. Chawla, MD
- Inspection Date: 2022-04-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Sant P. Chawla, MD, Clinical Investigator, in Santa Monica, CA, revealed a significant protocol deviation during a human clinical study. The investigator failed to immediately hold a subject's investigational drug despite becoming aware of abnormal laboratory results, leading to the subject continuing the drug for several days and subsequently being hospitalized with serious conditions. This indicates a critical failure in patient safety and adherence to the investigational plan.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.globalkeysolutions.net/companies/sant-p-chawla-md/12b13bee-4e0f-4d72-a3a7-217e48fb68ef

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