FDA Inspection 1009751 — Remel Inc.
The FDA completed an inspection of Remel Inc. on April 12, 2017 in Oakwood Village, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oakwood Village, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |