Warning letter

The Compounding Pharmacy of America: warning letter of Jun 9, 2016

FDA warning letter 476703 · New Orleans District Office

Key facts

Reference number 476703
Company The Compounding Pharmacy of America
Subject CGMP/Compounded Drugs/Misbranding
Issue date Jun 9, 2016
Posted date Jun 14, 2016
Issuing office New Orleans District Office
Product type Drugs
CFR sections cited 211.166(a), 201.115, 210, 211, 211.28(a), 211.42(c)(10)(ii), 211.42(c)(10)(iii), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b)
Inspection city Knoxville
Inspection ZIP 37919
Inspection start date May 12, 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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