FDA inspection
CeramTec GmbH, Medical Products Division: FDA inspection ending Jan 19, 2023
FDA inspection 1197933 · Marktredwitz
Key facts
| Inspection ID | 1197933 |
|---|---|
| Firm | CeramTec GmbH, Medical Products Division |
| FEI number | 3001278222 |
| Address | Ceramtec-Weg 1 |
| City | Marktredwitz |
| Fiscal year | 2023 |
| Inspection end date | Jan 19, 2023 |
| Project area | Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data