Warning letter

NuVasive Inc: warning letter of Mar 12, 2013

FDA warning letter 392911 · Los Angeles District Office

Key facts

Reference number 392911
Company NuVasive Inc
Subject Premarket Approval/Misbranded/Adulterated
Issue date Mar 12, 2013
Posted date Mar 12, 2013
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 807.81(a)(3)(ii), 807.81(b)
Inspection city San Diego
Inspection ZIP 92121
Inspection start date Oct 29, 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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