FDA Inspection
Greiner Bio-One GmbHGreiner Bio-One GmbH – FDA Inspection, Oct 25, 2018
Record Details
This FDA Inspection record concerns Greiner Bio-One GmbH, with an inspection on October 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c998d201-79b4-4c1e-916b-2e6be589cec0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1069716
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Greiner Bio-One GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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