FDA Inspection
Hsmg, Inc. D/b/a Smartinfuser UsaHsmg, Inc. D/b/a Smartinfuser Usa – FDA Inspection, Dec 18, 2009
Record Details
This FDA Inspection record concerns Hsmg, Inc. D/b/a Smartinfuser Usa, with an inspection on December 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 18, 2009
- Product Type
- Devices
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ID · fffad4fb-9dda-4fcb-89e9-a1fcdb1ab778
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 633532
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(a)General
- 21 CFR 820.25(b)Training - Lack of or inadequate 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 |
|---|---|---|---|
| January 25, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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