Warning letter

Dexta Corporation: warning letter of Jun 25, 2014

FDA warning letter 424400 · San Francisco District Office

Key facts

Reference number 424400
Company Dexta Corporation
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jun 25, 2014
Posted date Jul 1, 2014
Issuing office San Francisco District Office
Product type Devices
CFR sections cited 820, 820.40
Inspection city Napa
Inspection ZIP 94558
Inspection start date Mar 4, 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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