FDA Inspection
Ortho-Clinical Diagnostics, Inc.Ortho-Clinical Diagnostics, Inc. – FDA Inspection, May 10, 2019
Record Details
This FDA Inspection record concerns Ortho-Clinical Diagnostics, Inc., with an inspection on May 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9cb815b1-2313-4d59-a9dd-5e4ca9e37013
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089858
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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 22, 2025 | NAI | New York District Office | Postmarket Assurance: Medical 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 1256840 - 2025-05-22
- FDA Inspection 1012815 - 2017-06-02
- FDA Inspection 929799 - 2015-05-15
- FDA Inspection 773151 - 2012-02-08
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