FDA Inspection
Koros USA, Inc.Koros USA, Inc. – FDA Inspection, Dec 19, 2024
Record Details
This FDA Inspection record concerns Koros USA, Inc., with an inspection on December 19, 2024, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · dbcc75de-c126-4a7b-b393-d1648c71b7af
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1257646
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Koros USA, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 14, 2014 | 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 1163411 - 2022-02-16
- FDA Inspection 991885 - 2016-11-14
- FDA Inspection 867690 - 2014-02-14
- FDA Inspection 682640 - 2010-09-23
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