Heartware, Inc. - Miami Lakes, United States - FDA Site Report

FEI Number: 3007042319

Overview Statistics

Total Inspections

Total 483s Issued

Warning Letters Issued

62.5%

483 Issue Rate

Last Inspected: 2021-09-30

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Date	Investigators	Category	Days
2021-09-30	Dianiris C Ayala Stanley B Eugene Karen M Rodriguez	Medical Devices & Rad Health	113 days
2018-07-12	Dianiris C Ayala Karen M Rodriguez	Medical Devices & Rad Health	57 days
2016-05-04	Dianiris C Ayala Sean T Creighton	Medical Devices & Rad Health	31 days
2014-01-24	Richard K Vogel	Medical Devices & Rad Health	12 days
2013-08-30	Dawn M Mccabe	Medical Devices & Rad Health	16 days
2013-03-29	Dawn M Mccabe	Medical Devices & Rad Health	9 days
2012-03-05	Dianiris C Ayala Dawn M Mccabe	-	-
2011-07-20	Dawn M Mccabe	-	-

Last Updated: 2025-05-14 06:13:03