FDA Inspection
Leonhard Lang Medizintechnik GmbHLeonhard Lang Medizintechnik GmbH – FDA Inspection, Nov 20, 2014
Record Details
This FDA Inspection record concerns Leonhard Lang Medizintechnik GmbH, with an inspection on November 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2014
- Product Type
- Devices
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ID · 9ec09e64-52fe-4442-a0d0-53e507643847
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906898
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
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Other FDA inspections of Leonhard Lang Medizintechnik GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2019 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
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