# FDA 483 - Sujith R. Kalmadi, MD - July 16, 2021

Source: https://www.globalkeysolutions.net/records/483/sujith-r-kalmadi-md/60a2cd52-0111-49f3-9c50-c61156a2d0b8

> FDA 483 for Sujith R. Kalmadi, MD on July 16, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sujith R. Kalmadi, MD
- Inspection Date: 2021-07-16
- Product Type: other
- Office Name: Denver District Office
- Summary: Ironwood Cancer and Research Centers in Chandler, AZ, was inspected as a clinical investigator and received two observations. The firm failed to conduct an investigational study in accordance with the signed agreement and investigational plan, specifically regarding radiological assessments for two subjects. Additionally, subject records were incomplete, as a reported adverse event of skin tears from an investigational device was not properly documented or evaluated.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sujith-r-kalmadi-md/8d6206ed-5c78-4f2d-bf27-36cac19157d2

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face