Warning letter

GVS Filter Technology UK Ltd: warning letter of Jan 23, 2015

FDA warning letter 445394 · Center for Devices and Radiological Health

Key facts

Reference number 445394
Company GVS Filter Technology UK Ltd
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jan 23, 2015
Posted date Jan 23, 2015
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Morecambe
Inspection start date Jul 21, 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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