FDA Inspection 845108 — Oscor Inc.
The FDA completed an inspection of Oscor Inc. on August 21, 2013 in Palm Harbor, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 21, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Palm Harbor, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5142 | 21 CFR 1040.10(e)(2) | Compliance test conditions |