FDA Inspection
Imorgon Medical LLCImorgon Medical LLC – FDA Inspection, Aug 31, 2011
Record Details
This FDA Inspection record concerns Imorgon Medical LLC, with an inspection on August 31, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Imorgon Medical LLC
- Inspection Date
- August 31, 2011
- Product Type
- Devices
View Company Profile
ID · b9e8a78a-bee6-41d7-94d0-bb3dcbec0e10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741564
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Imorgon Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Imorgon Medical LLC
- FDA Inspection 1080784 - 2019-02-05
- FDA Inspection 901731 - 2014-10-29
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.