FDA Inspection
2035 PMA2035 PMA – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns 2035 PMA, with an inspection on September 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 2035 PMA
- Inspection Date
- September 13, 2013
- Product Type
- Devices
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ID · 33b028f3-14ac-4dbf-8122-2e6f1cff8d2b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 847869
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
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Other FDA inspections of 2035 PMA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 3, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 27, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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