HeartWare Inc.
Amended 483 issued July 12, 2018 · Miami Lakes, Florida
- Inspection
- May 17 – Jul 12, 2018
- Investigators
- Dianiris C. Ayala· Karen M. Rodriguez
- Observations
- 7
- Pages
- 16
- FEI number
- 3007042319
In short: On July 12, 2018, FDA issued a Amended 483 with 7 observations to HeartWare Inc. in Miami Lakes, Florida (FEI 3007042319) after an inspection that ran May 17 – Jul 12, 2018. The investigators were Dianiris C. Ayala and Karen M. Rodriguez. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
3 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
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 firmHeartWare Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at HeartWare Inc.?
FDA listed 7 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected HeartWare Inc.?
Dianiris C. Ayala and Karen M. Rodriguez are named on this Amended 483, for the inspection of May 17 – Jul 12, 2018. Each investigator has a profile showing what they cite most.
When was HeartWare Inc. inspected by FDA?
The inspection ran May 17 – Jul 12, 2018, and the Amended 483 is dated July 12, 2018.
How do I get the full Amended 483 for HeartWare Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.