# FDA 483 - Alvin C. Silva, MD - December 05, 2025

Source: https://www.globalkeysolutions.net/records/483/alvin-c-silva-md/670b1727-2ac6-4071-a778-166b2fa37648

> FDA 483 for Alvin C. Silva, MD on December 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvin C. Silva, MD
- Inspection Date: 2025-12-05
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Alvin C. Silva, MD, a clinical investigator in Phoenix, AZ, received a Form 483 citing three observations during an FDA inspection. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding the delayed reporting of a serious adverse event. Additionally, issues were found with maintaining adequate and accurate case histories, including data discrepancies and unclear adverse event reporting, and informed consent was not properly documented.

## Related Officers

- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/stephanie-barragan/fc1bc901-1467-4fdd-bee3-f87f2db3a1fa)

Company: https://www.globalkeysolutions.net/companies/alvin-c-silva-md/3f037466-bdf9-463a-b03a-59fcd97b15b7

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