FDA Inspection
Arrow International, Inc. (subsidiary of Teleflex, Inc.)Arrow International, Inc. (subsidiary of Teleflex, Inc.) – FDA Inspection, Feb 28, 2011
Record Details
This FDA Inspection record concerns Arrow International, Inc. (subsidiary of Teleflex, Inc.), with an inspection on February 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 28, 2011
- Product Type
- Devices
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ID · bdd8ce55-0608-4b14-b60f-e46dbfab46c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711599
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Arrow International, Inc. (subsidiary of Teleflex, Inc.)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 7, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 1, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arrow International, Inc. (subsidiary of Teleflex, Inc.)
- FDA Inspection 1146471 - 2021-06-16
- FDA Inspection 891557 - 2014-08-22
- FDA Inspection 854476 - 2013-11-07
- FDA Inspection 763683 - 2012-02-01
- FDA Inspection 640302 - 2010-02-25
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