Warning letter

Contract Medical Manufacturing: warning letter of Nov 20, 2008

FDA warning letter 41699 · New England District Office

Key facts

Reference number 41699
Company Contract Medical Manufacturing
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Nov 20, 2008
Posted date Nov 20, 2008
Issuing office New England District Office
Product type Devices
CFR sections cited 806, 820
Inspection city Oxford
Inspection ZIP 06478-1190
Inspection start date Sep 10, 2008
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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