FDA Inspection
Owen Mumford USA, Inc.FDA Inspection 740437 - Owen Mumford USA, Inc. - August 10, 2011
Record Details
This FDA Inspection record concerns Owen Mumford USA, Inc., with an inspection on August 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Owen Mumford USA, Inc.
- Inspection Date
- August 10, 2011
- Product Type
- Devices
View Company Profile
ID · e258fab1-5128-4ec7-9fce-489d29081898
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 740437
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 803.40(b)Report of malfunction likely to cause death or injury
Full citation text and observation details available on the Dashboard.
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 |
| December 12, 2013 | OAI | 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 859742 - 2013-12-12
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