FDA Inspection
Arrow International LLCArrow International LLC – FDA Inspection, Jul 16, 2015
Record Details
This FDA Inspection record concerns Arrow International LLC, with an inspection on July 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arrow International LLC
- Inspection Date
- July 16, 2015
- Product Type
- Devices
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ID · 21db3d26-7998-47cb-913a-1d86aec882bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939353
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Arrow International LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2016 | 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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