Warning letter

DIMA S.L.: warning letter of Oct 15, 2014

FDA warning letter 439076 · Center for Devices and Radiological Health

Key facts

Reference number 439076
Company DIMA S.L.
Subject Medical Devices/Adulterated/Quality System Regulation (QSR)
Issue date Oct 15, 2014
Posted date Dec 30, 2014
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Calatayud
Inspection start date Jun 30, 2014
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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