FDA inspection

Fresenius Medical Care North America - Texas: FDA inspection ending Nov 19, 2020

FDA inspection 1133913 · No Action Indicated (NAI) · Irving, TX

Key facts

Inspection ID 1133913
Firm Fresenius Medical Care North America - Texas
FEI number 3003310249
Address 5201 Regent Blvd Ste 100
City Irving
State TX
ZIP 75063-2428
Fiscal year 2021
Inspection end date Nov 19, 2020
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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