FDA Inspection 866244 — Rowny Systems, Inc.
The FDA completed an inspection of Rowny Systems, Inc. on February 10, 2014 in Cabin John, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 10, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cabin John, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |