FDA Inspection
Zenith DiagnosticsZenith Diagnostics – FDA Inspection, Nov 20, 2018
Record Details
This FDA Inspection record concerns Zenith Diagnostics, with an inspection on November 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · cc0b9a9b-3b79-45a8-86dd-68fe348a2d11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072319
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.