HeartWare Inc.
FDA inspection history across 2 sites, 2011 to 2018
- 2
- Form 483s
- 2
- Warning letters
- 2
- EIRs
Every document, by year
- Form 483
- Warning letter
- EIR
2011: one inspection report; 2013: one inspection report; 2014: two warning letters; 2016: one Form 483; 2018: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011–18Two inspection reports, two warning letters, one Form 483 and one amended 483, at Miami Lakes, Florida and Framingham, Massachusetts.
- 2018The longest 483 on file: 7 observations over 16 pages at Miami Lakes, Florida.
Cited most
Across all HeartWare observations on file
- 21 CFR 820.30(a)Design controls3
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.50Purchasing controls2
The complete HeartWare file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Miami Lakes, Florida
Two inspection reports, one amended 483, one Form 483 and one warning letter · 2011 to 2018 · 14 observations
Latest: Form 483, Jul 12, 2018 →Framingham, Massachusetts
One warning letter · 2014
Latest: Warning letter, Jun 2, 2014 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-07-12 | Amended 483 Amended 483 | Miami Lakes, Florida | 7 | $99 |
| 2016-05-04 | 483 Form 483 | Miami Lakes, Florida | 7 | $99 |
| 2014-06-02 | Warning letter Warning letter | Framingham, Massachusetts | — | $99 |
| 2014-06-02 | Warning letter Warning letter | Miami Lakes, Florida | — | $99 |
| 2013-03-29 | EIR EIR | Miami Lakes, Florida | — | $550 |
| 2011-07-20 | EIR EIR | Miami Lakes, Florida | — | $550 |
Investigators on these documents
Dawn M. McCabe (2)Dianiris C. Ayala (2)Karen M. Rodriguez (1)Sean T. Creighton (1)
FEI number 3007042319 · most recent document Jul 12, 2018
About HeartWare Inc.
How many FDA Form 483s has HeartWare Inc. received?
FDA Intel has 2 Form 483s on file for HeartWare Inc.; the most recent is dated Jul 12, 2018.
When was HeartWare Inc. last inspected by FDA?
The most recent FDA inspection document on file for HeartWare Inc. is a Form 483 dated Jul 12, 2018, for the site in Miami Lakes, Florida.
What did FDA cite at HeartWare Inc.?
The regulations cited most in the observations on file for HeartWare Inc. are 21 CFR 820.30(a) (Design controls), 3 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times.
Has HeartWare Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for HeartWare Inc.; the most recent is dated Jun 2, 2014.