Company
United StatesAscension St. Mary's Hospital, Saginaw, MI – FDA Inspections
Inspection records and compliance data for Ascension St. Mary's Hospital in Saginaw, Michigan. 6 FDA inspections on record, last inspected September 05, 2019.
Company Profile
This profile covers Ascension St. Mary's Hospital based in Saginaw, Michigan, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 9, 2009. Last inspected September 5, 2019.
Most cited issue areas
- Concurrent documentation2 inspections
- Establish, maintain and follow manufacturing SOPs2 inspections
- Legibility and indelibility1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2019 | NAI | Biologics · Blood and Blood Products | 1105242 |
| January 26, 2017 | NAI | Biologics · Blood and Blood Products | 999240 |
| February 26, 2015 | VAI | Biologics · Blood and Blood Products | 916243 |
| February 28, 2013 | VAI | Biologics · Blood and Blood Products | 820805 |
| February 4, 2011 | VAI | Biologics · Blood and Blood Products | 711732 |
| January 9, 2009 | VAI | Biologics · Blood and Blood Products | 560468 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ascension St. Mary's Hospital
FEI Number
1000041176
Address
800 S Washington Ave, Saginaw, Michigan 48601, United States
Country
United States
ID: 2cc598e3-24fc-4279-b31b-1f81811a0008