Company
AustriaGreiner Bio-One GmbH, Oberoesterreich, Austria – FDA Inspections
Inspection records and compliance data for Greiner Bio-One GmbH in Oberoesterreich, 4550. 2 FDA inspections on record (1 OAI), 2 Form 483s, last inspected December 21, 2023.
Company Profile
This profile covers Greiner Bio-One GmbH based in Oberoesterreich, 4550, Austria.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected October 25, 2018. Last inspected December 21, 2023.
Most cited issue areas
- Lack of Written MDR Procedures2 inspections
- Complaints1 inspection
- Design control - no procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 21, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1226348 |
| October 25, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1069716 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
Greiner Bio-One GmbH
FEI Number
3000974732
Address
Kremsmuenster, Oberoesterreich, 4550 Austria, Austria
Country
Austria
ID: 3eeba95c-99e8-4ab8-8478-7dbc994a4970