Warning letter

Stewart Compounding Pharmacy: warning letter of Aug 21, 2013

FDA warning letter 398215 · Atlanta District Office

Key facts

Reference number 398215
Company Stewart Compounding Pharmacy
Subject CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Issue date Aug 21, 2013
Posted date Aug 21, 2013
Issuing office Atlanta District Office
Product type Drugs
CFR sections cited 211.113(b), 211.167(a), 211.166(a), 201.115, 211, 211.28(a), 211.42(c)(10)(iv), 211.165(a)
Inspection city Fayetteville
Inspection ZIP 28305
Inspection start date Mar 18, 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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