Warning letter

Coastal Meds, LLC.: warning letter of Jun 22, 2016

FDA warning letter 490967 · New Orleans District Office

Key facts

Reference number 490967
Company Coastal Meds, LLC.
Subject CGMP/Compounded Drugs/Misbranding
Issue date Jun 22, 2016
Posted date Jun 28, 2016
Issuing office New Orleans District Office
Product type Drugs
CFR sections cited 210, 211.192, 200.10(b), 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.166(a), 210.1(b), 201.115
Inspection city Biloxi
Inspection ZIP 39532
Inspection start date Sep 15, 2015
Letter on fda.gov web.archive.org

At a glance

  • 10–99 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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