FDA Inspection
Insite OneInsite One – FDA Inspection, Sep 1, 2017
Record Details
This FDA Inspection record concerns Insite One, with an inspection on September 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 8e8b322d-faa7-46ba-bd3f-6b516ba480e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023771
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 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 Insite One
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2025 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
Other documents for Insite One
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.