FDA Inspection
ProCon Implants GmbHProCon Implants GmbH – FDA Inspection, Jan 25, 2018
Record Details
This FDA Inspection record concerns ProCon Implants GmbH, with an inspection on January 25, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · d3ecbc23-deb4-4d2b-b259-c97cb17ec6cb
Inspection Facts
- Inspection number
- 1038538
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ProCon Implants GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ProCon Implants GmbH
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.