FDA Inspection
Owen Mumford USA, Inc.FDA Inspection 859742 - Owen Mumford USA, Inc. - December 12, 2013
Record Details
This FDA Inspection record concerns Owen Mumford USA, Inc., with an inspection on December 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Owen Mumford USA, Inc.
- Inspection Date
- December 12, 2013
- Product Type
- Devices
View Company Profile
ID · 64979699-2657-4a0e-ac0f-3595d676bf40
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 859742
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Owen Mumford USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 31, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 10, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Owen Mumford USA, Inc.
- FDA Inspection 1098838 - 2019-03-05
- FDA Inspection 904740 - 2014-10-31
- FDA Inspection 740437 - 2011-08-10
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