FDA Inspection
Westone Laboratories, Inc.Westone Laboratories, Inc. – FDA Inspection, Nov 15, 2017
Record Details
This FDA Inspection record concerns Westone Laboratories, Inc., with an inspection on November 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d7062be9-1d5c-4934-aabb-5c95e309edd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031336
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Westone Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 12, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 6, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Westone Laboratories, Inc.
- FDA Inspection 814099 - 2013-01-14
- FDA Inspection 790503 - 2012-07-12
- FDA Inspection 579412 - 2009-04-06
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