FDA Inspection
CeramTec GmbH, Medical Products DivisionCeramTec GmbH, Medical Products Division – FDA Inspection, Feb 14, 2018
Record Details
This FDA Inspection record concerns CeramTec GmbH, Medical Products Division, with an inspection on February 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · efa786bf-a0cc-4a94-9524-939d7da0f593
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1041074
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.72(a)Equipment control activity documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CeramTec GmbH, Medical Products Division
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 10, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CeramTec GmbH, Medical Products Division
- FDA Inspection 1198717 - 2023-02-09
- FDA Inspection 932190 - 2015-06-10
- FDA Inspection 773131 - 2012-02-09
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