FDA Inspection 866413 — Ranir, LLC
The FDA completed an inspection of Ranir, LLC on February 27, 2014 in Grand Rapids, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Grand Rapids, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3159 | 21 CFR 820.184 | DHR content |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |