FDA Inspection
Interojo Inc.Interojo Inc. – FDA Inspection, Aug 29, 2019
Record Details
This FDA Inspection record concerns Interojo Inc., with an inspection on August 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · fe72b567-386b-4e3e-847a-491f4a30a1f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101815
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.184(f)DHR - UDI not included
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Interojo Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2018 | Not classified | Office of Inspections and Investigations | |
| July 18, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Interojo Inc.
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.