FDA Inspection
Mogen InstrumentsMogen Instruments – FDA Inspection, Jul 2, 2012
Record Details
This FDA Inspection record concerns Mogen Instruments, with an inspection on July 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mogen Instruments
- Inspection Date
- July 2, 2012
- Product Type
- Devices
View Company Profile
ID · 9ef4bc76-00ae-4b8a-bcb6-1c89eb6d2f75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789185
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mogen Instruments
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 3, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mogen Instruments
- FDA Inspection 813220 - 2013-01-03
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.