Warning letter

Amresco LLC: warning letter of Feb 26, 2013

FDA warning letter 392384 · Cincinnati District Office

Key facts

Reference number 392384
Company Amresco LLC
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Feb 26, 2013
Posted date Feb 26, 2013
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 820
Inspection city Solon
Inspection ZIP 44139
Inspection start date Oct 15, 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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