FDA issued a Warning Letter to Cardiac Designs Inc. on 8/7/2015 as a result of this inspection.
483 Cardiac Designs Jul 2015

483 Cardiac Designs Jul 2015

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FDA investigators audited the Cardiac Designs - Round Rock, TX, United States facility and issued 11 inspectional observations (via FDA 483) on 02 Jul 2015.

Product details

  • Category: Medical Devices & Rad Health
  • Number of Observations: 11
  • Inspection end: 02 Jul 2015
  • Location: Round Rock, United States
  • FEI: 3010665082
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