FDA Inspection
Sunstar Americas IncSunstar Americas Inc – FDA Inspection, Feb 17, 2015
Record Details
This FDA Inspection record concerns Sunstar Americas Inc, with an inspection on February 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunstar Americas Inc
- Inspection Date
- February 17, 2015
- Product Type
- Devices
View Company Profile
ID · b9351d2b-0d3a-4196-92d1-61484238a793
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 915187
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Sunstar Americas Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sunstar Americas Inc
- FDA Inspection 743934 - 2011-08-29
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