Warning letter

DMX-Works, Inc.: warning letter of Oct 26, 2012

FDA warning letter 329678 · Florida District Office

Key facts

Reference number 329678
Company DMX-Works, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Oct 26, 2012
Posted date Oct 26, 2012
Issuing office Florida District Office
Product type Devices
CFR sections cited 1010.3(a), 1020.30(h)(6), 1020.30(j), 1020.30, 1020.30(d)(1), 820, 1002.11, 1002.13, 1002.13(b)
Inspection city Palm Harbor
Inspection ZIP 34683
Inspection start date Jun 4, 2012
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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