Warning letter

First Medical Source LLC: warning letter of Sep 26, 2012

FDA warning letter 322718 · Los Angeles District Office

Key facts

Reference number 322718
Company First Medical Source LLC
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Sep 26, 2012
Posted date Sep 26, 2012
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 807.81(b), 803, 803.3, 803.17, 803.50, 803.17(a)(1), 803.20(c)(1), 820, 803.50(a)
Inspection city Laguna Niguel
Inspection ZIP 92677
Inspection start date Apr 26, 2012
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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