FDA issued a Warning Letter to SynCardia Systems LLC on 4/3/2018 as a result of this inspection.
483 SynCardia Systems Aug 2017

483 SynCardia Systems Aug 2017

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FDA investigators audited the SynCardia Systems - Tucson, AZ, United States facility and issued inspectional observations (via FDA 483) on 18 Aug 2017.

Product details

  • Category: Medical Devices & Rad Health
  • Inspection end: 18 Aug 2017
  • Location: Tucson, United States
  • FEI: 3003761017
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