FDA inspection

Fresenius Medical Care North America - Texas: FDA inspection ending Jan 7, 2013

FDA inspection 813351 · Voluntary Action Indicated (VAI) · Irving, TX

Key facts

Inspection ID 813351
Firm Fresenius Medical Care North America - Texas
FEI number 3003310249
Address 5201 Regent Blvd Ste 100
City Irving
State TX
ZIP 75063
Country United States
Fiscal year 2013
Inspection end date Jan 7, 2013
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 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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