Warning letter

Orthopedic Alliance: warning letter of Feb 3, 2012

FDA warning letter 235834 · Los Angeles District Office

Key facts

Reference number 235834
Company Orthopedic Alliance
Subject CGMP/QSR/Adulterated/Misbranded
Issue date Feb 3, 2012
Posted date Feb 3, 2012
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 803, 803.17, 820
Inspection city Murrieta
Inspection ZIP 92562
Inspection start date Jul 20, 2011
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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