Heartware, Inc.
FDA inspection history in Framingham, Massachusetts, 2015 to 2017
- 1
- EIR
- 1
- Form 483
Every document, by year
- EIR
- Form 483
2015: one Form 483; 2017: one inspection report.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17One Form 483 and one inspection report, at Framingham, Massachusetts.
Cited most
Across all Heartware observations on file
- 21 CFR 820.30(g)Design controls3
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.50Purchasing controls1
The complete Heartware file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Framingham, Massachusetts
One inspection report and one Form 483 · 2015 to 2017 · 6 observations
Latest: EIR, Jul 20, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-07-20 | EIR EIR | Framingham, Massachusetts | — | $550 |
| 2015-07-31 | 483 Form 483 | Framingham, Massachusetts | 6 | $99 |
Investigators on these documents
FEI number 3010767211 · most recent document Jul 20, 2017
About Heartware, Inc.
How many FDA Form 483s has Heartware, Inc. received?
FDA Intel has 1 Form 483 on file for Heartware, Inc.; the most recent is dated Jul 31, 2015.
When was Heartware, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Heartware, Inc. is an establishment inspection report (EIR) dated Jul 20, 2017, for the site in Framingham, Massachusetts.
What did FDA cite at Heartware, Inc.?
The regulations cited most in the observations on file for Heartware, Inc. are 21 CFR 820.30(g) (Design controls), 3 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time.