Warning letter

Montana Compounding Pharmacy PC: warning letter of May 9, 2018

FDA warning letter 521947 · Los Angeles District Office

Key facts

Reference number 521947
Company Montana Compounding Pharmacy PC
Subject Compounding Pharmacy/Adulterated Drug Products
Issue date May 9, 2018
Posted date May 9, 2018
Issuing office Los Angeles District Office
Product type Drugs
CFR sections cited 216, 200.10(b), 211.42(b), 211.56(a), 211.84(d)(2), 211.84(d)(6), 211.166(a), 210.1(b)
Inspection city Missoula
Inspection ZIP 59802
Inspection start date Aug 30, 2016
Letter on fda.gov fda.gov

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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