Warning letter

The Compounding Shop, Inc.: warning letter of Aug 12, 2014

FDA warning letter 409122 · Florida District Office

Key facts

Reference number 409122
Company The Compounding Shop, Inc.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Aug 12, 2014
Posted date Aug 26, 2014
Issuing office Florida District Office
Product type Drugs
CFR sections cited 201.115, 211, 200.10(b), 211.28(a), 211.42(c)(10)(iv), 211.113(b), 211.165(a), 211.166(a), 211.167(a), 210.1(b)
Inspection city St Petersburg
Inspection ZIP 33709
Inspection start date Aug 23, 2013
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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