Warning letter

W & C dba The Apothecary: warning letter of Jul 20, 2017

FDA warning letter 508183 · Detroit District Office

Key facts

Reference number 508183
Company W & C dba The Apothecary
Subject Compounding Pharmacy/Adulterated Drug Products
Issue date Jul 20, 2017
Posted date Jul 20, 2017
Issuing office Detroit District Office
Product type Drugs
CFR sections cited 201.115, 211.42(c), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.165(f)
Inspection city Sartell
Inspection ZIP 56377
Inspection start date Jun 6, 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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