FDA Inspection
Ortho Clinical Diagnostics GmbhFDA Inspection 917103 - Ortho Clinical Diagnostics Gmbh - February 12, 2015
Record Details
This FDA Inspection record concerns Ortho Clinical Diagnostics Gmbh, with an inspection on February 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 12, 2015
- Product Type
- Devices
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ID · bec7ebdf-8856-4e62-91cc-f85be347879c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 917103
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Ortho Clinical Diagnostics Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 7, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ortho Clinical Diagnostics Gmbh
- FDA Inspection 981517 - 2016-07-07
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