FDA issued a Warning Letter to HeartWare Inc on 6/2/2014 for a previous inspection.
483 Heartware May 2016

483 Heartware May 2016

Dianiris Ayala FDA, Sean Creighton FDA$119.00 - Available Now

FDA investigators audited the Heartware - Miami Lakes, FL, United States facility and issued 7 inspectional observations (via FDA 483) on 04 May 2016.

Product details

  • Category: Medical Devices & Rad Health
  • Number of Observations: 7
  • Inspection end: 04 May 2016
  • Location: Miami Lakes, United States
  • FEI: 3007042319
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