FDA Inspection
The Standing CompanyThe Standing Company – FDA Inspection, May 20, 2010
Record Details
This FDA Inspection record concerns The Standing Company, with an inspection on May 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Standing Company
- Inspection Date
- May 20, 2010
- Product Type
- Devices
View Company Profile
ID · aa494751-bb4e-4913-8cbf-2a9fe3940f94
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 663510
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)General
- 21 CFR 820.100(a)(1)Statistical methodology
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(a)Implement quality policy
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
Showing 10 of 11 citations.
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Other FDA inspections of The Standing Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 27, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 8, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The Standing Company
- FDA Inspection 937172 - 2015-08-06
- FDA Inspection 857835 - 2013-12-06
- FDA Inspection 826588 - 2013-03-27
- FDA Inspection 710540 - 2011-02-08
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