FDA Inspection
Statcorp MedicalStatcorp Medical – FDA Inspection, Sep 3, 2010
Record Details
This FDA Inspection record concerns Statcorp Medical, with an inspection on September 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Statcorp Medical
- Inspection Date
- September 3, 2010
- Product Type
- Devices
View Company Profile
ID · 7fbb3ea9-74b7-4a9a-8c31-6ac39594a62e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 679463
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Statcorp Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2018 | Not classified | Seattle District Office | |
| October 28, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Statcorp Medical
- FDA Inspection 1081705 - 2018-03-08
- FDA Inspection 854300 - 2013-10-28
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