FDA Inspection
CeramTec GmbH, Medical Products DivisionCeramTec GmbH, Medical Products Division – FDA Inspection, Apr 29, 2010
Record Details
This FDA Inspection record concerns CeramTec GmbH, Medical Products Division, with an inspection on April 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 29, 2010
- Product Type
- Devices
View Company Profile
ID · 34779fc4-18a8-483a-8dd2-508c9020ae22
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 665629
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.25(a)Sufficient personnel
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
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 |
|---|---|---|---|
| January 19, 2023 | Not classified | Office of Inspections and Investigations | |
| February 16, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 12, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CeramTec GmbH, Medical Products Division
- FDA Inspection 1197933 - 2023-01-19
- FDA Inspection 1041252 - 2018-02-16
- FDA Inspection 932193 - 2015-06-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.