FDA Inspection
KORR Medical Technologies, Inc.KORR Medical Technologies, Inc. – FDA Inspection, Nov 7, 2016
Record Details
This FDA Inspection record concerns KORR Medical Technologies, Inc., with an inspection on November 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 2cb49d36-690a-4b7a-ac73-e651530e1418
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991323
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of KORR Medical Technologies, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 10, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 3, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for KORR Medical Technologies, Inc.
- FDA Inspection 1164820 - 2022-03-17
- FDA Inspection 878261 - 2014-05-10
- FDA Inspection 722658 - 2011-05-03
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.