FDA Inspection
Arrow International, Inc. (subsidiary of Teleflex, Inc.)Arrow International, Inc. (subsidiary of Teleflex, Inc.) – FDA Inspection, Feb 25, 2010
Record Details
This FDA Inspection record concerns Arrow International, Inc. (subsidiary of Teleflex, Inc.), with an inspection on February 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 25, 2010
- Product Type
- Devices
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ID · 7df0932c-2b81-4012-a06e-acb66ba0ff28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 803.52(b)(2)Death
- 21 CFR 803.52(b)(2)(iii)Injury or Illness Requiring Intervention
- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product control
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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 28, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 711599 - 2011-02-28
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