FDA Inspection
Hsmg, Inc. D/b/a Smartinfuser UsaHsmg, Inc. D/b/a Smartinfuser Usa – FDA Inspection, Jan 25, 2011
Record Details
This FDA Inspection record concerns Hsmg, Inc. D/b/a Smartinfuser Usa, with an inspection on January 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 25, 2011
- Product Type
- Devices
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ID · ef614a14-9edb-4f97-b3a2-fbef460fead9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 704975
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.40(a)Report of death, injury
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hsmg, Inc. D/b/a Smartinfuser Usa
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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