Warning letter

Customed, Inc [ARCHIVED]: warning letter of Sep 11, 2009

FDA warning letter 74243 · San Juan District Office

Key facts

Reference number 74243
Company Customed, Inc [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Sep 11, 2009
Posted date Sep 11, 2009
Issuing office San Juan District Office
Product type Devices
CFR sections cited 820
Inspection city Fajardo
Inspection ZIP 00738
Inspection start date Mar 31, 2009
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • VAI 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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