Warning letter

Medical Device Resource Corp: warning letter of Oct 9, 2012

FDA warning letter 328258 · San Francisco District Office

Key facts

Reference number 328258
Company Medical Device Resource Corp
Subject Premarket Approval/Misbranded/Adulterated
Issue date Oct 9, 2012
Posted date Oct 9, 2012
Issuing office San Francisco District Office
Product type Devices
CFR sections cited 807.81(a)(3)(ii), 807.81(a)(3)
Inspection city Livermore
Inspection ZIP 94550
Inspection start date Mar 26, 2012
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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