FDA Inspection
Greiner Bio-One North America, Inc.Greiner Bio-One North America, Inc. – FDA Inspection, Oct 29, 2021
Record Details
This FDA Inspection record concerns Greiner Bio-One North America, Inc., with an inspection on October 29, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 29, 2021
- Product Type
- Devices
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ID · 99c892db-61ca-4cac-87a2-3fefadc27d6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155664
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.186QSR
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Other FDA inspections of Greiner Bio-One North America, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2019 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 24, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Greiner Bio-One North America, Inc.
- FDA Inspection 1222303 - 2023-09-14
- FDA Inspection 1114241 - 2019-12-13
- FDA Inspection 1021970 - 2017-08-17
- FDA Inspection 843981 - 2013-07-24
- FDA Inspection 703137 - 2010-12-07
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