Warning letter

Montana Compounding Pharmacy: warning letter of Dec 11, 2015

FDA warning letter 477564 · Seattle District Office

Key facts

Reference number 477564
Company Montana Compounding Pharmacy
Subject Compounding Pharmacy/Adulteration/Misbranding
Issue date Dec 11, 2015
Posted date Jan 19, 2016
Issuing office Seattle District Office
Product type Drugs
CFR sections cited 201.115, 211, 211.111, 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.56(a), 211.84(d)(2), 211.84(d)(6), 211.113(b), 211.167(a)
Inspection city Missoula
Inspection ZIP 59802
Inspection start date Apr 28, 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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