FDA Inspection 551179 — Stat Medical Devices, Inc.
The FDA completed an inspection of Stat Medical Devices, Inc. on December 5, 2008 in North Miami Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 5, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- North Miami Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |