FDA Inspection
Sysmex America, Inc.Sysmex America, Inc. – FDA Inspection, Oct 28, 2009
Record Details
This FDA Inspection record concerns Sysmex America, Inc., with an inspection on October 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sysmex America, Inc.
- Inspection Date
- October 28, 2009
- Product Type
- Devices
View Company Profile
ID · 177b2c0b-360d-45a7-b832-af1ef89b6722
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 626786
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.40Sponsors" general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sysmex America, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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