Company
United StatesSt. Vincent Hospital and Health Care Inc., Indianapolis, IN – FDA Inspections
Inspection records and compliance data for St. Vincent Hospital and Health Care Inc. in Indianapolis, Indiana. 6 FDA inspections on record, 1 Form 483, last inspected March 21, 2024.
Company Profile
This profile covers St. Vincent Hospital and Health Care Inc. based in Indianapolis, Indiana, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 1, 2010. Last inspected March 21, 2024.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Person performing, test results, interpretation2 inspections
- Blood not stored between 1-6 deg / shipped 1-10 deg1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2024 | NAI | Biologics · Blood and Blood Products | 1234776 |
| June 6, 2018 | VAI | Biologics · Blood and Blood Products | 1055155 |
| August 10, 2016 | VAI | Biologics · Blood and Blood Products | 983436 |
| July 18, 2014 | NAI | Biologics · Blood and Blood Products | 887805 |
| June 20, 2012 | VAI | Biologics · Blood and Blood Products | 787512 |
| June 1, 2010 | NAI | Biologics · Blood and Blood Products | 664272 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
St. Vincent Hospital and Health Care Inc.
FEI Number
1873396
Address
2001 W 86th St, Indianapolis, Indiana 46260, United States
Country
United States
ID: 5e2ec577-b881-41c5-8edc-4c2283752acc