Warning letter

Abbott Molecular [ARCHIVED]: warning letter of Aug 12, 2009

FDA warning letter 70264 · Chicago District Office

Key facts

Reference number 70264
Company Abbott Molecular [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Aug 12, 2009
Posted date Aug 12, 2009
Issuing office Chicago District Office
Product type Devices
CFR sections cited 820
Inspection city Des Plaines
Inspection ZIP 60018
Inspection start date Jun 2, 2009
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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