# FDA 483 - Wills Eye Hospital IRB - October 17, 2025

Source: https://www.globalkeysolutions.net/records/483/wills-eye-hospital-irb/f9598ed5-76cc-442b-baed-b9881c47b344

> FDA 483 for Wills Eye Hospital IRB on October 17, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wills Eye Hospital IRB
- Inspection Date: 2025-10-17
- Product Type: other
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Wills Eye Hospital IRB in Philadelphia revealed significant deficiencies in its written procedures. The Institutional Review Board lacked established protocols for verifying material changes, reporting unanticipated problems, addressing noncompliance, and handling the suspension or termination of IRB approvals. These issues indicate a systemic failure to maintain adequate procedural controls for critical IRB functions.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gabrielle-j-swain/55f33430-41dc-4fae-bac0-ec6ea340feb6)

Company: https://www.globalkeysolutions.net/companies/wills-eye-hospital-irb/ab9fcb83-a482-4eeb-b895-293048258409

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8