# FDA 483 - Mitali Wadekar, M.D. - February 01, 2019

Source: https://www.globalkeysolutions.net/records/483/mitali-wadekar-md/91679020-fc6a-4393-ab88-fadda73c3da4

> FDA 483 for Mitali Wadekar, M.D. on February 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mitali Wadekar, M.D.
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Mitali Wadekar, M.D. in Panorama City, CA, revealed significant deficiencies in the conduct of a human clinical study involving an investigational drug. The clinical investigator failed to adhere to the investigational plan, leading to multiple protocol deviations. These issues included under-dosing of study participants, failure to perform required urine drug screens, improper storage of study drug outside specified temperature ranges, and a missed blood chemistry panel.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/mitali-wadekar-md/d8f9c290-6f40-45e6-8f79-14f7ef472f2e

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