FDA Inspection
Sysmex America, Inc.Sysmex America, Inc. – FDA Inspection, Feb 6, 2012
Record Details
This FDA Inspection record concerns Sysmex America, Inc., with an inspection on February 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sysmex America, Inc.
- Inspection Date
- February 6, 2012
- Product Type
- Devices
View Company Profile
ID · caeeeaf2-e424-4893-a145-65d958e772a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769601
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Sysmex America, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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