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, None, 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
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| July 7, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 12, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Documents (4)
FDA Inspection 981517 - Ortho Clinical Diagnostics Gmbh - 2016-07-07
fda_inspection
FDA Inspection 981517 - Ortho Clinical Diagnostics Gmbh - 2016-07-07
fda_inspection
WARNING_LETTER - Ortho Clinical Diagnostics Gmbh - 2015-02-12
WARNING_LETTER
FDA Inspection 917103 - Ortho Clinical Diagnostics Gmbh - 2015-02-12
fda_inspection
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Search nearby companiesCompany Information
Name
Ortho Clinical Diagnostics Gmbh
FEI Number
3001665564
State
None
City
Neckargemund
ID: 0300cc1a-6e71-4869-b2e6-4e526cbdaaa2