FDA Inspection
Arrow International LLCArrow International LLC – FDA Inspection, Dec 18, 2009
Record Details
This FDA Inspection record concerns Arrow International LLC, with an inspection on December 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arrow International LLC
- Inspection Date
- December 18, 2009
- Product Type
- Devices
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ID · 7db9a3db-b438-4d30-b7f5-f123a60625f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635947
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.198(e)(5)Nature and details of complaint
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Arrow International LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 20, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arrow International LLC
- FDA Inspection 1211561 - 2023-07-14
- FDA Inspection 977560 - 2016-06-20
- FDA Inspection 897017 - 2014-09-24
- FDA Inspection 859917 - 2013-12-18
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