FDA Inspection
Arrow International LLCArrow International LLC – FDA Inspection, Jun 20, 2016
Record Details
This FDA Inspection record concerns Arrow International LLC, with an inspection on June 20, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arrow International LLC
- Inspection Date
- June 20, 2016
- Product Type
- Devices
View Company Profile
ID · f67838c9-727e-4063-85b5-1612048389ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 977560
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(a)Production processes
Full citation text and observation details available on the Dashboard.
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 |
| September 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Arrow International LLC
- FDA Inspection 1211561 - 2023-07-14
- FDA Inspection 897017 - 2014-09-24
- FDA Inspection 859917 - 2013-12-18
- FDA Inspection 635947 - 2009-12-18
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