# FDA 483 - Sri Sundaram, M.D. - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/sri-sundaram-md/86c28309-7845-4496-ac8b-f4a270074e16

> FDA 483 for Sri Sundaram, M.D. on January 13, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sri Sundaram, M.D.
- Inspection Date: 2023-01-13
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Sri Sundaram, M.D., a clinical investigator in Littleton, CO, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, adverse events for several enrolled subjects were not reported as required by the protocol. A second observation concerning inaccurate subject records was removed following discussions with management.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.globalkeysolutions.net/companies/sri-sundaram-md/139c7d82-01ba-4456-9d6e-326b4a8bb06a

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