FDA Inspection 640014 — Internal Fixation Systems, Inc.
The FDA completed an inspection of Internal Fixation Systems, Inc. on Jan 13, 2010 in Medley, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 13, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2627 | 21 CFR 820.30(e) | Design reviews performed following schedule |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |