Warning letter

Intersurgical, Ltd. [ARCHIVED]: warning letter of Dec 27, 2011

FDA warning letter 251294 · Center for Devices and Radiological Health

Key facts

Reference number 251294
Company Intersurgical, Ltd. [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Misbranded
Issue date Dec 27, 2011
Posted date Dec 27, 2011
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 803, 803.17, 820, 820.40
Inspection city Wokingham
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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