# FDA 483 - Valley Health/Winchester Medical Center IRB - August 09, 2022

Source: https://www.globalkeysolutions.net/records/483/valley-healthwinchester-medical-center-irb/4fe254d7-e0e3-4a79-a5ed-d4ad3b4eec75

> FDA 483 for Valley Health/Winchester Medical Center IRB on August 09, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valley Health/Winchester Medical Center IRB
- Inspection Date: 2022-08-09
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Valley Health/Winchester Medical Center IRB in Winchester, VA, revealed significant procedural deficiencies. The IRB failed to properly determine device study risk, maintain accurate lists of its members, and ensure detailed meeting minutes reflecting voting actions. These issues indicate a need for improved oversight and documentation practices within the IRB.

## Related Documents

- [WARNING_LETTER - 2013-02-01](https://www.globalkeysolutions.net/records/warning_letter/valley-healthwinchester-medical-center-irb/07e0085d-a8a4-44b0-a601-a379b93e8243)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/melanie-n-daniels/51d7ddf0-f1af-4e42-ba4c-9a18200f42a9)

Company: https://www.globalkeysolutions.net/companies/valley-healthwinchester-medical-center-irb/8aefdfea-c4d5-4df4-bb95-cec8343eafa6

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64