FDA Inspection
Ortho-Clinical Diagnostics, Inc.Ortho-Clinical Diagnostics, Inc. – FDA Inspection, Sep 28, 2017
Record Details
This FDA Inspection record concerns Ortho-Clinical Diagnostics, Inc., with an inspection on September 28, 2017, issued by the New Jersey District Office, covering medical devices & rad health.
- Inspection Date
- September 28, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ee81fd44-7e7e-493d-a595-8da9b7f925dc
Inspection Facts
- Inspection number
- 1041687
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
Other FDA inspections of Ortho-Clinical Diagnostics, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | Not classified | New Jersey District Office | |
| December 9, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 18, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 16, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ortho-Clinical Diagnostics, Inc.
- FDA Inspection 1264865 - 2025-06-13
- FDA Inspection 1192367 - 2022-12-09
- FDA Inspection 1054495 - 2018-04-18
- FDA Inspection 1002540 - 2016-07-28
- FDA Inspection 918943 - 2015-03-16
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