FDA Inspection
Leonhard Lang Medizintechnik GmbHLeonhard Lang Medizintechnik GmbH – FDA Inspection, Jul 24, 2019
Record Details
This FDA Inspection record concerns Leonhard Lang Medizintechnik GmbH, with an inspection on July 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · a6905f45-2a8e-46b4-b063-b072f4a56841
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097388
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR content
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Leonhard Lang Medizintechnik GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Leonhard Lang Medizintechnik 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.