# FDA 483 - Johns Hopkins University School of Medicine IRB - September 07, 2001

Source: https://www.globalkeysolutions.net/records/483/johns-hopkins-university-school-of-medicine-irb/838b5bdc-9b2a-4456-9c4e-2611e268ea8c

> FDA 483 for Johns Hopkins University School of Medicine IRB on September 07, 2001. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Johns Hopkins University School of Medicine IRB
- Inspection Date: 2001-09-07
- Office Name: Baltimore District Office
- Summary: The FDA Form 483 documents observations from an inspection, citing failures in maintaining adequate documentation and following written procedures for an Institutional Review Board (IRB).

**Facility and Operation Details:** The observations pertain to an IRB's operations, specifically regarding the review and approval of research protocols.

**Violations and Observations:**
1.  **Inadequate Meeting Minutes:** The facility failed to prepare and maintain adequate documentation of minutes for six out of 21 fully convened IRB meetings on 1/9/00, 1/23/00, 2/13/00, 3/13/00, 3/27/00, and 4/10/00.
2.  **Conflict of Interest Documentation:** IRB minutes lacked sufficient detail to determine if an IRB member with a conflicting interest in project RPN #00-11-07-02 (approved 12/12/00) participated in its initial review or voting, despite being present.
3.  **Failure to Follow Written Procedures for Initial Review:** The IRB failed to follow its written procedure (Guideline IV. A. Full Board/Committee Review) requiring significant issues, comments, or questions regarding protocols to be sent to the subcommittee and then forwarded to the investigator in writing for a response prior to the fully convened meeting.
    *   **Study RPN #00-1

## Related Officers

- [Lab Tech 1 at Washington County Department of Waste Water Management](https://www.globalkeysolutions.net/people/diann-shaffer/9fb6bbf8-b3a7-4e1f-a3c6-e8a0a73db200)
- [Investigator ](https://www.globalkeysolutions.net/people/gerald-w-miller/c0dd4bef-0dd0-4bef-be69-99a396183ca3)

Company: https://www.globalkeysolutions.net/companies/johns-hopkins-university-school-of-medicine-irb/f319969f-7e51-4cf1-8d38-d27f6c58e361

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa