Warning letter

American Aesthetics Medical Supply, Inc.: warning letter of Sep 23, 2013

FDA warning letter 397346 · Dallas District Office

Key facts

Reference number 397346
Company American Aesthetics Medical Supply, Inc.
Subject Medical Device Reporting/Misbranded
Issue date Sep 23, 2013
Posted date Sep 23, 2013
Issuing office Dallas District Office
Product type Devices
CFR sections cited 803, 803.17, 820, 820.3, 807.81(b)
Inspection city Dallas
Inspection ZIP 75234
Inspection start date Mar 14, 2013
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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