FDA Inspection
Koros USA, Inc.Koros USA, Inc. – FDA Inspection, Feb 14, 2014
Record Details
This FDA Inspection record concerns Koros USA, Inc., with an inspection on February 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Koros USA, Inc.
- Inspection Date
- February 14, 2014
- Product Type
- Devices
View Company Profile
ID · 06edf2fa-0ac0-4a29-9779-40d1ee709e75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867690
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Koros USA, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2024 | NAI | Los Angeles District Office | Postmarket Assurance: Medical Devices |
| February 16, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 23, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Koros USA, Inc.
- FDA Inspection 1257646 - 2024-12-19
- FDA Inspection 1163411 - 2022-02-16
- FDA Inspection 991885 - 2016-11-14
- FDA Inspection 682640 - 2010-09-23
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.