Warning letter

CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V.: warning letter of May 7, 2012

FDA warning letter 287859 · Center for Devices and Radiological Health

Key facts

Reference number 287859
Company CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V.
Subject Device/Adulterated
Issue date May 7, 2012
Posted date May 7, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Mexicali
Inspection start date Jan 23, 2012
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

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

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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