Company
United StatesAscension St. John Hospital IRB, Grosse Pointe Woods, MI – FDA Inspections
Inspection records and compliance data for Ascension St. John Hospital IRB in Grosse Pointe Woods, Michigan. 3 FDA inspections on record, 1 Form 483, last inspected August 12, 2022.
Company Profile
This profile covers Ascension St. John Hospital IRB based in Grosse Pointe Woods, Michigan, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 21, 2012. Last inspected August 12, 2022.
Most cited issue areas
- Conflict of interest1 inspection
- Investigational device represented as safe and /or effective1 inspection
- Prompt reporting of unanticipated problems1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 12, 2022 | NAI | Biologics, Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 1178321 |
| December 23, 2016 | VAI | Human Drugs · Bioresearch Monitoring | 997372 |
| March 21, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 776083 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Sterling Institutional Review Board
Human Research Protection Program, Medical College of WI-IRB
Forrest General Hospital IRB
St. Vincent's Health System IRB
U Of MN Research Subjects' Protection Program/ IRB
St Vincent's Medical Center IRB
Northwestern University IRB
North Broward Hospital District IRB
University of Massachusetts Chan Medical School IRB
ProMedica Health System IRB
Company Information
Name
Ascension St. John Hospital IRB
FEI Number
1833142
Address
19251 Mack Ave Ste 340, Grosse Pointe Woods, Michigan 48236, United States
Country
United States
ID: 87dd009f-bbd8-406a-8811-e7a81bc7999d