FDA Inspection
Arrow International, Inc. (subsidiary of Teleflex, Inc.)Arrow International, Inc. (subsidiary of Teleflex, Inc.) – FDA Inspection, Nov 7, 2013
Record Details
This FDA Inspection record concerns Arrow International, Inc. (subsidiary of Teleflex, Inc.), with an inspection on November 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 7, 2013
- Product Type
- Devices
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ID · a0d53764-0dd4-4266-abe8-4fdafc523f66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 854476
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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 |
| February 1, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 763683 - 2012-02-01
- FDA Inspection 711599 - 2011-02-28
- FDA Inspection 640302 - 2010-02-25
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