FDA inspection

Edwards Lifesciences Technology SARL: FDA inspection ending Mar 24, 2017

FDA inspection 1018411 · No Action Indicated (NAI) · Anasco, PR

Key facts

Inspection ID 1018411
Firm Edwards Lifesciences Technology SARL
FEI number 2648045
Address Hwy # 402 North, Km 1.4
City Anasco
State PR
ZIP 610
Fiscal year 2017
Inspection end date Mar 24, 2017
Classification No Action Indicated (NAI)
Project area Compliance: Medical Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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