Company
GermanyOrtho Clinical Diagnostics Gmbh - Inspection Records
Inspection records and compliance data for Ortho Clinical Diagnostics Gmbh in Neckargemund. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected July 07, 2016.
Company Profile
This profile covers Ortho Clinical Diagnostics Gmbh based in Neckargemund, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected February 12, 2015. Last inspected July 7, 2016.
Most cited issue areas
- DHR content1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures for handling1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 7, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 981517 |
| February 12, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 917103 |
FDA documents
Warning Letters (1)
Company Information
Name
Ortho Clinical Diagnostics Gmbh
FEI Number
3001665564
Address
Karl-Landsteiner-Str. 1, Neckargemund, Germany
Country
Germany
ID: 0300cc1a-6e71-4869-b2e6-4e526cbdaaa2