FDA Inspection
Arrow International LLCArrow International LLC – FDA Inspection, Jul 1, 2016
Record Details
This FDA Inspection record concerns Arrow International LLC, with an inspection on July 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arrow International LLC
- Inspection Date
- July 1, 2016
- Product Type
- Devices
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ID · 986e1ff0-4c14-46c4-9c18-b37612fd3fca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986015
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Arrow International LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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