FDA Inspection
Duerr Optronik Gmbh & Co. KGDuerr Optronik Gmbh & Co. KG – FDA Inspection, Sep 12, 2019
Record Details
This FDA Inspection record concerns Duerr Optronik Gmbh & Co. KG, with an inspection on September 12, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Duerr Optronik Gmbh & Co. KG
- Inspection Date
- September 12, 2019
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 607ea887-da23-418b-b13d-6134ae16fba5
Inspection Facts
- Inspection number
- 1101905
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
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.