FDA Inspection
Rhinosystems IncRhinosystems Inc – FDA Inspection, Dec 2, 2016
Record Details
This FDA Inspection record concerns Rhinosystems Inc, with an inspection on December 2, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Edward R. Kay (Issuing Officer)
View Company Profile
ID · bcaab9a8-6c2a-44cd-af86-47c2d726ba01
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996259
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rhinosystems Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rhinosystems Inc
- FDA Inspection 1228863 - 2024-02-08
- FDA Inspection 649782 - 2010-03-04
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.