FDA Inspection
Radformation Inc.Radformation Inc. – FDA Inspection, Mar 5, 2019
Record Details
This FDA Inspection record concerns Radformation Inc., with an inspection on March 5, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · db51da43-d947-4f4f-8b7b-2102d390fe61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082097
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Radformation Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Radformation Inc.
- FDA Inspection 1162046 - 2021-12-17
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.