FDA Inspection 633532 — Hsmg, Inc. D/b/a Smartinfuser Usa
The FDA completed an inspection of Hsmg, Inc. D/b/a Smartinfuser Usa on December 18, 2009 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 4189 | 21 CFR 820.198(a) | General |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |