FDA Inspection
Greiner Bio-One North America, Inc.Greiner Bio-One North America, Inc. – FDA Inspection, Jul 24, 2013
Record Details
This FDA Inspection record concerns Greiner Bio-One North America, Inc., with an inspection on July 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 24, 2013
- Product Type
- Devices
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ID · e2c4f6df-eb67-4054-90a5-5c80eb823cc0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843981
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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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 |
| August 17, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1021970 - 2017-08-17
- FDA Inspection 703137 - 2010-12-07
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