FDA Inspection
Procon Medizintechnik GmbHProcon Medizintechnik GmbH – FDA Inspection, Sep 21, 2018
Record Details
This FDA Inspection record concerns Procon Medizintechnik GmbH, with an inspection on September 21, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Procon Medizintechnik GmbH
- Inspection Date
- September 21, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 85ba75b3-a581-4620-88a4-8fead42e9935
Inspection Facts
- Inspection number
- 1066249
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 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 Medizintechnik GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Procon Medizintechnik GmbH
- FDA Inspection 722522 - 2011-04-06
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.