Company
GermanyProCon Implants GmbH, Tuttlingen, Germany – FDA Inspections
Inspection records and compliance data for ProCon Implants GmbH in Tuttlingen. 2 FDA inspections on record, 1 Form 483, last inspected January 25, 2018.
Company Profile
This profile covers ProCon Implants GmbH based in Tuttlingen, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 11, 2013. Last inspected January 25, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 25, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1038538 |
| December 11, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 861307 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ProCon Implants GmbH
FEI Number
3007766698
Address
Rudolf-Diesel-Str. 18, Rudolf-Diesel-Strasse 24, Tuttlingen, Germany
Country
Germany
ID: a0c51576-6a16-4403-b4dd-499fdce14800