SynCardia Systems Inc.
FDA inspection history in Tucson, Arizona, 2015 to 2019
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2015: one Form 483; 2018: one close-out letter; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Tucson, Arizona.
- 2018–19Two close-out letters, at Tucson, Arizona.
Cited most
Across all SynCardia Systems observations on file
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.90(a)Nonconforming product1
The complete SynCardia Systems file.
All 3 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
Tucson, Arizona
Two close-out letters and one Form 483 · 2015 to 2019 · 2 observations
Latest: Close-out, Jun 11, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-11 | Close-out Close-out letter | Tucson, Arizona | — | $99 |
| 2018-04-03 | Close-out Close-out letter | Tucson, Arizona | — | $99 |
| 2015-04-17 | 483 Form 483 | Tucson, Arizona | 2 | $99 |
Investigators on these documents
FEI number 3003761017 · most recent document Jun 11, 2019
About SynCardia Systems Inc.
How many FDA Form 483s has SynCardia Systems Inc. received?
FDA Intel has 1 Form 483 on file for SynCardia Systems Inc.; the most recent is dated Apr 17, 2015.
When was SynCardia Systems Inc. last inspected by FDA?
The most recent FDA inspection document on file for SynCardia Systems Inc. is a Form 483 dated Apr 17, 2015, for the site in Tucson, Arizona.
What did FDA cite at SynCardia Systems Inc.?
The regulations cited most in the observations on file for SynCardia Systems Inc. are 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.90(a) (Nonconforming product), 1 time.