Warning letter

Meditech Kft.: warning letter of Jul 18, 2012

FDA warning letter 314858 · Center for Devices and Radiological Health

Key facts

Reference number 314858
Company Meditech Kft.
Subject Adulterated Device/Misbranding
Issue date Jul 18, 2012
Posted date Jul 18, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 803, 820, 820.40
Inspection city Budapest
Inspection start date Apr 10, 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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