FDA Inspection 649429 — Electrostim Medical Services Inc
The FDA completed an inspection of Electrostim Medical Services Inc on February 24, 2010 in Tampa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 24, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |