FDA Inspection
Ortho-Clinical DiagnosticsOrtho-Clinical Diagnostics – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Ortho-Clinical Diagnostics, with an inspection on March 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f4f1545e-49cd-4e0e-85eb-85ccead383b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013474
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(f)Design verification - output does not meet input requirement
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