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FDA Inspection
•Synergy Health Ireland Ltd.•November 3, 2017

Synergy Health Ireland Ltd. – FDA Inspection, Nov 3, 2017

Record Details

This FDA Inspection record concerns Synergy Health Ireland Ltd., with an inspection on November 3, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Synergy Health Ireland Ltd.
Inspection Date
November 3, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Jude C. Dike (Investigator)
View Company Profile

ID · c2fdb44e-7d26-4aef-9e91-d97d76f3f070

Inspection Facts

Inspection number
1030608
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.100(a)Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Synergy Health Ireland Ltd.

4
DateClassificationOfficeProject area
January 18, 2018NAICenter for Devices and Radiological HealthCompliance: Devices
July 17, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
February 15, 2012NAICenter for Devices and Radiological HealthBioresearch Monitoring
April 26, 2010NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Synergy Health Ireland Ltd.
  • FDA Inspection 1040730 - 2018-01-18
  • FDA Inspection 934934 - 2015-07-17
  • FDA Inspection 767405 - 2012-02-15
  • FDA Inspection 665775 - 2010-04-26

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