FDA Inspection
Avalign Delivery Systems DivisionAvalign Delivery Systems Division – FDA Inspection, May 23, 2018
Record Details
This FDA Inspection record concerns Avalign Delivery Systems Division, with an inspection on May 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ee9ceb13-8351-416c-a121-fe9a8c965200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053732
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Avalign Delivery Systems Division
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 9, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 30, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Avalign Delivery Systems Division
- FDA Inspection 889789 - 2014-08-05
- FDA Inspection 793541 - 2012-08-09
- FDA Inspection 580993 - 2009-04-30
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