# FDA 483 - Mercy Medical Center IRB - June 24, 2008

Source: https://www.keypedia.com/records/483/mercy-medical-center-irb/cd70a7a6-47d6-4ddf-8922-c679c0d0af06

> FDA 483 for Mercy Medical Center IRB on June 24, 2008. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mercy Medical Center IRB
- Inspection Date: 2008-06-24
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Mercy Medical Center IRB in Baltimore, MD, was cited for significant deficiencies in its operations, primarily concerning record-keeping and procedural controls. The inspection revealed a failure to maintain essential research records, improper use of expedited review, and a lack of timely continuing review for studies. Furthermore, the IRB repeatedly lacked critical written procedures for conducting reviews and for reporting unanticipated problems, noncompliance, and approval suspensions or terminations to the FDA.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephanie-l-shapley/5677033b-5e51-4a15-a8a7-53e73350d8e1)
- [other](https://www.keypedia.com/people/lakisha-m-williams/e3eb02df-a9d7-4c2c-8a54-380b52b10dfa)

Company: https://www.keypedia.com/companies/mercy-medical-center-irb/5c55604c-ebe7-4915-9eec-137f7af61b63

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e