Warning letter

Fresenius USA Manufacturing, Inc.: warning letter of Mar 5, 2013

FDA warning letter 393723 · Denver District Office

Key facts

Reference number 393723
Company Fresenius USA Manufacturing, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Mar 5, 2013
Posted date Mar 5, 2013
Issuing office Denver District Office
Product type Devices
CFR sections cited 820
Country 1
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited

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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