FDA Inspection
Zeno CorporationZeno Corporation – FDA Inspection, Jun 21, 2010
Record Details
This FDA Inspection record concerns Zeno Corporation, with an inspection on June 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zeno Corporation
- Inspection Date
- June 21, 2010
- Product Type
- Devices
View Company Profile
ID · 722595fa-3af5-40d2-b122-fd61ea0bf686
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 665001
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zeno Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Zeno Corporation
- FDA Inspection 735758 - 2011-08-01
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.