FDA Inspection 867690 — Koros USA, Inc.
The FDA completed an inspection of Koros USA, Inc. on Feb 14, 2014 in Moorpark, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Moorpark, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |