FDA Inspection
Ortho-Clinical Diagnostics, Inc.Ortho-Clinical Diagnostics, Inc. – FDA Inspection, May 22, 2025
Record Details
This FDA Inspection record concerns Ortho-Clinical Diagnostics, Inc., with an inspection on May 22, 2025, issued by the New York District Office, covering medical devices & rad health.
- Inspection Date
- May 22, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 07e6e7e2-3fd3-41f8-b173-18f7b6380a1e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1256840
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ortho-Clinical Diagnostics, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 2, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 15, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 8, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ortho-Clinical Diagnostics, Inc.
- FDA Inspection 1089858 - 2019-05-10
- FDA Inspection 1012815 - 2017-06-02
- FDA Inspection 929799 - 2015-05-15
- FDA Inspection 773151 - 2012-02-08
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