FDA Inspection
IBP Medical GmbhIBP Medical Gmbh – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns IBP Medical Gmbh, with an inspection on May 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8ed0e17-2b05-4e35-9ef8-f7e1405c9562
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053191
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of IBP Medical Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 12, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for IBP Medical Gmbh
- FDA Inspection 1258331 - 2024-12-11
- FDA Inspection 630049 - 2009-11-12
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