FDA Inspection 710479 — Internal Fixation Systems, Inc.
The FDA completed an inspection of Internal Fixation Systems, Inc. on Apr 28, 2011 in Medley, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 28, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |