FDA Inspection
LRE Medical GmbHLRE Medical GmbH – FDA Inspection, Jul 26, 2018
Record Details
This FDA Inspection record concerns LRE Medical GmbH, with an inspection on July 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 45f4076b-6e63-479c-b67d-f2af26ff6db0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061475
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of LRE Medical GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LRE Medical GmbH
- FDA Inspection 1012391 - 2017-02-03
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