Company
United StatesKoros USA, Inc., Moorpark, CA – FDA Inspections
Inspection records and compliance data for Koros USA, Inc. in Moorpark, California. 5 FDA inspections on record, 2 Form 483s, last inspected December 19, 2024.
Company Profile
This profile covers Koros USA, Inc. based in Moorpark, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 23, 2010. Last inspected December 19, 2024.
Most cited issue areas
- Documentation2 inspections
- Lack of or inadequate final acceptance procedures2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1257646 |
| February 16, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1163411 |
| November 14, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 991885 |
| February 14, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 867690 |
| September 23, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 682640 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Koros USA, Inc.
FEI Number
2023918
Address
610 Flinn Ave, Moorpark, California 93021, United States
Country
United States
ID: aef01499-e1c2-4032-9567-2c00bf7fbcbb