# FDA 483 - Mehrdad Kevin Ariani, MD - October 04, 2019

Source: https://www.globalkeysolutions.net/records/483/mehrdad-kevin-ariani-md/9c55cecd-05fb-45c0-8326-1191ac5385ab

> FDA 483 for Mehrdad Kevin Ariani, MD on October 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mehrdad Kevin Ariani, MD
- Inspection Date: 2019-10-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Mehrdad Kevin Ariani, MD, a clinical investigator in Northridge, CA, was inspected by the FDA from 9/30/2019 to 10/4/2019. The inspection revealed significant deviations from the investigational plan and protocol, including enrolling subjects who did not meet inclusion criteria and failing to report a serious adverse event to the CRO within the required timeframe. These findings indicate a failure to conduct investigations in accordance with established protocols.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/angela-shepas/743113c1-799b-44e9-9422-8049c476bfd2)

Company: https://www.globalkeysolutions.net/companies/mehrdad-kevin-ariani-md/f1791633-5c28-4409-8104-c5225c0cf3a1

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