FDA Inspection
Greiner Bio-One GmbHGreiner Bio-One GmbH – FDA Inspection, Dec 21, 2023
Record Details
This FDA Inspection record concerns Greiner Bio-One GmbH, with an inspection on December 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d1a2a428-2799-48e1-a020-885b852c03b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1226348
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(a)Complaints
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Other FDA inspections of Greiner Bio-One GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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