FDA Inspection
Surgistar IncSurgistar Inc – FDA Inspection, Jun 30, 2011
Record Details
This FDA Inspection record concerns Surgistar Inc, with an inspection on June 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Surgistar Inc
- Inspection Date
- June 30, 2011
- Product Type
- Devices
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ID · 6f0414ca-c562-492f-acfc-c3245089c9d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 732565
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Surgistar Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Surgistar Inc
- FDA Inspection 980305 - 2016-08-05
- FDA Inspection 815299 - 2012-12-12
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