FDA Inspection
Arrow International, Inc. (subsidiary of Teleflex, Inc.)Arrow International, Inc. (subsidiary of Teleflex, Inc.) – FDA Inspection, Aug 22, 2014
Record Details
This FDA Inspection record concerns Arrow International, Inc. (subsidiary of Teleflex, Inc.), with an inspection on August 22, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 22, 2014
- Product Type
- Devices
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ID · 6ec123d0-380e-4089-9c28-e8407da2c372
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891557
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.186QSR
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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 |
| 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 |
| 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 854476 - 2013-11-07
- FDA Inspection 763683 - 2012-02-01
- FDA Inspection 711599 - 2011-02-28
- FDA Inspection 640302 - 2010-02-25
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