FDA Inspection 1088104 — Koroad America, Inc.
The FDA completed an inspection of Koroad America, Inc. on May 1, 2019 in Newport Beach, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Newport Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |