SynCardia Systems Inc.
Form 483 issued April 17, 2015 · Tucson, Arizona
- Inspection
- Apr 13 – Apr 17, 2015
- Investigator
- Kimberly M. Lichter
- Observations
- 2
- Pages
- 2
- FEI number
- 3003761017
In short: On April 17, 2015, FDA issued a Form 483 with 2 observations to SynCardia Systems Inc. in Tucson, Arizona (FEI 3003761017) after an inspection that ran Apr 13 – Apr 17, 2015. The investigator was Kimberly M. Lichter. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×) · 820.90(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures have not been adequately established to control product that does not…
This inspection in context
Kimberly M. Lichter
1 document · 2015
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Arizona.
The firmSynCardia Systems Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SynCardia Systems Inc.?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected SynCardia Systems Inc.?
Kimberly M. Lichter is named on this Form 483, for the inspection of Apr 13 – Apr 17, 2015. Each investigator has a profile showing what they cite most.
When was SynCardia Systems Inc. inspected by FDA?
The inspection ran Apr 13 – Apr 17, 2015, and the Form 483 is dated April 17, 2015.
How do I get the full Form 483 for SynCardia Systems 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.