Company
GermanyORGENTEC Diagnostika Gmbh, Mainz, Germany – FDA Inspections
Inspection records and compliance data for ORGENTEC Diagnostika Gmbh in Mainz. 1 FDA inspection on record, last inspected May 02, 2013.
Company Profile
This profile covers ORGENTEC Diagnostika Gmbh based in Mainz, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected May 2, 2013.
Most cited issue areas
- Lack of or inadequate procedures for labeling1 inspection
- Training - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 2, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 835430 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ORGENTEC Diagnostika Gmbh
FEI Number
3003232042
Address
Carl-Zeiss-Str. 49-51, Mainz, Germany
Country
Germany
ID: 7ea00a00-6ab4-4c91-844c-3c5660d9866a