Edwards Lifesciences Technology SARL
Form 483 issued January 27, 2015 · Anasco, Puerto Rico
- Inspection
- Nov 6, 2014 – Jan 27, 2015
- Investigator
- Adaliz Santaliz-Cruz
- Observations
- 8
- Pages
- 6
- FEI number
- 2648045
In short: On January 27, 2015, FDA issued a Form 483 with 8 observations to Edwards Lifesciences Technology SARL in Anasco, Puerto Rico (FEI 2648045) after an inspection that ran Nov 6, 2014 – Jan 27, 2015. The investigator was Adaliz Santaliz-Cruz. Most observations concern production & process controls and laboratory controls.
At a glance
Production & process controls and laboratory controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
A validated process was not revalidated when changes…
- 03
Production processes were not controlled and monitored to ensure that a device…
- 04
Sampling plans are not based…
This inspection in context
Adaliz Santaliz-Cruz
6 documents · 2012–2022
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmEdwards Lifesciences Technology SARL history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edwards Lifesciences Technology SARL?
FDA listed 8 observations on this Form 483, mostly about production & process controls, laboratory controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Edwards Lifesciences Technology SARL?
Adaliz Santaliz-Cruz is named on this Form 483, for the inspection of Nov 6, 2014 – Jan 27, 2015. Each investigator has a profile showing what they cite most.
When was Edwards Lifesciences Technology SARL inspected by FDA?
The inspection ran Nov 6, 2014 – Jan 27, 2015, and the Form 483 is dated January 27, 2015.
How do I get the full Form 483 for Edwards Lifesciences Technology SARL?
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.