FDA Intel

HeartWare Inc.

Form 483 issued May 4, 2016 · Miami Lakes, Florida

Inspection
Apr 4 – May 4, 2016
Investigators
Dianiris C. Ayala· Sean T. Creighton
Observations
7
Pages
14
FEI number
3007042319

In short: On May 4, 2016, FDA issued a Form 483 with 7 observations to HeartWare Inc. in Miami Lakes, Florida (FEI 3007042319) after an inspection that ran Apr 4 – May 4, 2016. The investigators were Dianiris C. Ayala and Sean T. Creighton. Most observations concern cAPA and production & process controls.

At a glance

CAPA and production & process controls account for 6 of 7 observations.

CAPA3
Production & process controls3
Design controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 803.17

    Written MDR procedures have…

  2. 02
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have not been adequately established. Your firm has failed to…

  3. 03
    21 CFR 820.198(a)

    Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…

  4. 04
    21 CFR 820.75(a)

    A process whose results cannot be fully verified by subsequent inspection and test has not been…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Dianiris C. Ayala

8 documents · 2009–2024

Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.

The firm

HeartWare Inc. history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 803.17

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at HeartWare Inc.?

FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.

Who inspected HeartWare Inc.?

Dianiris C. Ayala and Sean T. Creighton are named on this Form 483, for the inspection of Apr 4 – May 4, 2016. Each investigator has a profile showing what they cite most.

When was HeartWare Inc. inspected by FDA?

The inspection ran Apr 4 – May 4, 2016, and the Form 483 is dated May 4, 2016.

How do I get the full Form 483 for HeartWare Inc.?

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