FDA Inspection
Ortho-Clinical Diagnostics, INc.Ortho-Clinical Diagnostics, INc. – FDA Inspection, Mar 27, 2017
Record Details
This FDA Inspection record concerns Ortho-Clinical Diagnostics, INc., with an inspection on March 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 641a64cb-4075-4218-ad59-4967a7288d02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012400
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.30(g)Design validation - Risk analysis
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