Warning letter

Amico Laboratories, Inc.: warning letter of Jan 3, 2008

FDA warning letter UCM1048453 · New Orleans District Office

Key facts

Reference number UCM1048453
Company Amico Laboratories, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issue date Jan 3, 2008
Posted date Jan 3, 2008
Issuing office New Orleans District Office
Product type Devices
CFR sections cited 803, 803.17, 862, 820, 820.40
Country 3
Inspection city Nashville
Inspection ZIP 37209-2108
Inspection start date Sep 10, 2007
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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