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FDA Inspection
•Teleflex Medical Europe Ltd•May 5, 2017

Teleflex Medical Europe Ltd – FDA Inspection, May 5, 2017

Record Details

This FDA Inspection record concerns Teleflex Medical Europe Ltd, with an inspection on May 5, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Teleflex Medical Europe Ltd
Inspection Date
May 5, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Jesse A. Vazquez (FDA Associated Person)
View Company Profile

ID · bd62d295-fc05-40b3-838d-78239af087e9

Inspection Facts

Inspection number
1017819
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Teleflex Medical Europe Ltd

2
DateClassificationOfficeProject area
June 5, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
November 4, 2010NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Teleflex Medical Europe Ltd
  • FDA Inspection 930829 - 2015-06-05
  • FDA Inspection 698018 - 2010-11-04

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