Heartware, Inc.

Form 483

Miami Lakes, Florida, United StatesFEI 3007042319Issued July 20, 2011

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3007042319.

Observations5

Issue DateJuly 20, 2011

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: Heartware, Inc.
Location: Miami Lakes, Florida, United States
FEI Number: 3007042319
Product Type: Devices
Issue Date: July 20, 2011
Country: United States

Inspection History, 2011 to 2018

NAI1

VAI1

OAI3

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

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Heartware, Inc. FDA Form 483, Miami Lakes, Florida, July 20, 2011