Warning letter

Riverpoint Medical, LLC: warning letter of May 1, 2013

FDA warning letter 394102 · Seattle District Office

Key facts

Reference number 394102
Company Riverpoint Medical, LLC
Subject CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issue date May 1, 2013
Posted date May 1, 2013
Issuing office Seattle District Office
Product type Devices
CFR sections cited 806.2(j), 820, 806.10(a)(2)
Inspection city Portland
Inspection ZIP 97232
Inspection start date Jan 25, 2013
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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