Company
GermanyCeramTec GmbH, Medical Products Division, Marktredwitz, Germany – FDA Inspections
Inspection records and compliance data for CeramTec GmbH, Medical Products Division in Marktredwitz. 4 FDA inspections on record, 2 Form 483s, last inspected January 19, 2023.
Company Profile
This profile covers CeramTec GmbH, Medical Products Division based in Marktredwitz, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 29, 2010. Last inspected January 19, 2023.
Most cited issue areas
- Statistical techniques - Lack of or inadequate procedures1 inspection
- Sufficient personnel1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 19, 2023 | Not classified | Medical Devices & Rad Health | 1197933 |
| February 16, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1041252 |
| June 12, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 932193 |
| April 29, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 665629 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CeramTec GmbH, Medical Products Division
FEI Number
3001278222
Address
Ceramtec-Weg 1, Marktredwitz, Germany
Country
Germany
ID: aeab5264-3819-4f6c-8993-8ad5023fdf33