LivaNova USA, Inc
Form 483 issued May 4, 2021 · Houston, Texas
- Inspection
- Apr 7 – May 4, 2021
- Investigator
- Ellen J. Tave
- Observations
- 1
- Pages
- 3
- FEI number
- 1000117004
In short: On May 4, 2021, FDA issued a Form 483 with 1 observation to LivaNova USA, Inc in Houston, Texas (FEI 1000117004) after an inspection that ran Apr 7 – May 4, 2021. The investigator was Ellen J. Tave. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Ellen J. Tave
8 documents · 2015–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmLivaNova USA, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LivaNova USA, Inc?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected LivaNova USA, Inc?
Ellen J. Tave is named on this Form 483, for the inspection of Apr 7 – May 4, 2021. Each investigator has a profile showing what they cite most.
When was LivaNova USA, Inc inspected by FDA?
The inspection ran Apr 7 – May 4, 2021, and the Form 483 is dated May 4, 2021.
How do I get the full Form 483 for LivaNova USA, 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.