# FDA WARNING_LETTER - Mercy Hospital Medical Center IRB - June 13, 2013

Source: https://www.keypedia.com/records/warning_letter/mercy-hospital-medical-center-irb/fef39a81-6444-4602-808b-a1d43d2c67bf

> FDA WARNING_LETTER for Mercy Hospital Medical Center IRB on June 13, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mercy Hospital Medical Center IRB
- Inspection Date: 2013-06-13
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Mercy Hospital & Medical Center Institutional Review Board (IRB) following an inspection from May 6 to June 13, 2013, which revealed significant violations of federal regulations governing IRBs, specifically 21 CFR Part 56, Part 50, and Part 812.

Key violations include:
1. **Failure to follow written procedures (21 CFR 56.108(a)(1))**: The IRB approved protocols for significant risk investigational devices without requiring the mandated IDE information (IDE number, FDA approval letter) as per its own SOPs.
2. **Failure to review research at convened meetings with a majority present (21 CFR 56.108(c))**: FDA-regulated research was reviewed when less than a majority of IRB members were present, compromising adequate review.
3. **Failure to prepare and maintain required written procedures (21 CFR 56.115(a)(6) and 56.108(a)(1)-(2))**: The IRB lacked written procedures for verifying no material changes in projects from sources other than the investigator, and for reporting findings/actions to the institution.
4. **Failure to retain IRB records for at least 3 years (21 CFR 56.115(b))**: Essential records like IRB rosters, meeting minutes, research proposals, and

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