Warning letter

Padtest, LLC: warning letter of Dec 17, 2014

FDA warning letter 443370 · Los Angeles District Office

Key facts

Reference number 443370
Company Padtest, LLC
Subject Medical Device Reporting/Misbranded
Issue date Dec 17, 2014
Posted date Jan 13, 2015
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 803, 803.17, 820, 820.40
Inspection city Scottsdale
Inspection ZIP 85260-3109
Inspection start date Sep 16, 2014
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • ADC 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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