Warning letter

Rocket Medical Plc [ARCHIVED]: warning letter of Oct 13, 2011

FDA warning letter 217075 · Center for Devices and Radiological Health

Key facts

Reference number 217075
Company Rocket Medical Plc [ARCHIVED]
Subject Adultered Device/Quality Control
Issue date Oct 13, 2011
Posted date Oct 13, 2011
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Tyne & Wear
Inspection start date Jul 11, 2011
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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