FDA Inspection
Derungs Licht AGDerungs Licht AG – FDA Inspection, Jul 4, 2019
Record Details
This FDA Inspection record concerns Derungs Licht AG, with an inspection on July 4, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · 0b87c991-5488-45fd-a309-56b6ae18af1a
Inspection Facts
- Inspection number
- 1095218
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Derungs Licht AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Derungs Licht AG
- FDA Inspection 1209643 - 2023-05-17
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.