FDA Inspection 704975 — Hsmg, Inc. D/b/a Smartinfuser Usa
The FDA completed an inspection of Hsmg, Inc. D/b/a Smartinfuser Usa on January 25, 2011 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 25, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 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 |