FDA Inspection
Arrow International LLCArrow International LLC – FDA Inspection, Feb 3, 2010
Record Details
This FDA Inspection record concerns Arrow International LLC, with an inspection on February 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arrow International LLC
- Inspection Date
- February 3, 2010
- Product Type
- Devices
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ID · ba5a43d7-10e5-4ff5-8e4a-6eff6af40238
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645882
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
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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 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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