FDA Inspection
Greiner Bio-One North America, Inc.Greiner Bio-One North America, Inc. – FDA Inspection, Aug 17, 2017
Record Details
This FDA Inspection record concerns Greiner Bio-One North America, Inc., with an inspection on August 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2d737c82-b54c-4dca-b236-3358f90507fe
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1021970
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.184DHR content
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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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 |
| October 29, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 13, 2019 | OAI | 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 1155664 - 2021-10-29
- FDA Inspection 1114241 - 2019-12-13
- FDA Inspection 843981 - 2013-07-24
- FDA Inspection 703137 - 2010-12-07
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