FDA Inspection 742300 — Norland At Swissray
The FDA completed an inspection of Norland At Swissray on September 13, 2011 in Mahwah, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mahwah, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |