# FDA WARNING_LETTER - Agnesian Healthcare IRB - November 13, 2012

Source: https://www.keypedia.com/records/warning_letter/agnesian-healthcare-irb/9f316b26-17dd-4b31-89cd-27b2b6c9ec3b

> FDA WARNING_LETTER for Agnesian Healthcare IRB on November 13, 2012. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Agnesian Healthcare IRB
- Inspection Date: 2012-11-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Agnesian Healthcare's Institutional Review Board (IRB) from November 7-13, 2012, revealed substantial failures to comply with 21 CFR parts 50 and 56, governing human subject protection in clinical investigations.

Key violations include:
1.  **Failure to maintain and follow written procedures:** The IRB lacked required written procedures for initial/continuing review, reporting findings, determining review frequency, ensuring prompt reporting of research changes, preventing unapproved changes, and reporting unanticipated problems, noncompliance, or IRB approval suspensions/terminations (21 CFR 56.108(a), 56.108(b), 56.115(a)(6)).
2.  **Failure to provide written notification of IRB decisions:** Investigators and the institution were only verbally informed of IRB decisions, lacking required written communication for approvals, disapprovals, or modifications (21 CFR 56.109(e)).
3.  **Inadequate documentation of IRB activities:** Meeting minutes failed to record the number of members abstaining from votes (21 CFR 56.115(a)(2)).
4.  **Failure to ensure basic elements of informed consent:** An IRB-approved consent form for Study (b)(4) omitted four serious risks (heart failure, decreased heart pumping ability, heart attack, pulmonary hypertension) despite prior notification

## Related Documents

- [483 - 2014-06-17](https://www.keypedia.com/records/483/agnesian-healthcare-irb/0539a462-475d-42f8-a018-c915f1409044)

## Related Officers

- [James P. Mugan](https://www.keypedia.com/people/james-p-mugan/65e2c9ed-e520-4042-a610-23e1cd4d9008)
- [Thomas N. Moreno](https://www.keypedia.com/people/thomas-n-moreno/c6b7a1f1-4b91-4d2c-898e-d0578c3eab7a)

Company: https://www.keypedia.com/companies/agnesian-healthcare-irb/ccc2128b-cff1-4956-943c-826172ca8b1b

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c