Company
GermanyLRE Medical GmbH, Nordlingen, Germany – FDA Inspections
Inspection records and compliance data for LRE Medical GmbH in Nordlingen. 2 FDA inspections on record, 1 Form 483, last inspected July 26, 2018.
Company Profile
This profile covers LRE Medical GmbH based in Nordlingen, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 3, 2017. Last inspected July 26, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
- Servicing - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1061475 |
| February 3, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1012391 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
LRE Medical GmbH
FEI Number
3003366417
Address
Hofer Str. 5, Nordlingen, Germany
Country
Germany
ID: 253e3a2e-bc30-4610-a9eb-faa9b19bd4b1