Company
GermanyCeramTec GmbH, Medical Products Division, Plochingen, Germany – FDA Inspections
Inspection records and compliance data for CeramTec GmbH, Medical Products Division in Plochingen. 4 FDA inspections on record, 1 Form 483, last inspected February 09, 2023.
Company Profile
This profile covers CeramTec GmbH, Medical Products Division based in Plochingen, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected February 9, 2012. Last inspected February 9, 2023.
Most cited issue areas
- Equipment control activity documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 9, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1198717 |
| February 14, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1041074 |
| June 10, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 932190 |
| February 9, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 773131 |
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
3002806653
Address
Building K, Ceramtec-Platz 1-9, Plochingen, Germany
Country
Germany
ID: e37d74ea-0e1d-4ae0-bf77-e401fe3e7eda