FDA Inspection 668336 — Mindray DS USA, Inc.
The FDA completed an inspection of Mindray DS USA, Inc. on June 10, 2010 in Mahwah, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mahwah, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |