Warning letter

Neuro-Fitness, L.L.C.: warning letter of Jan 30, 2006

FDA warning letter UCM075782 · Seattle District Office

Key facts

Reference number UCM075782
Company Neuro-Fitness, L.L.C.
Subject Lacks Premarket Approval Application Misbranded
Issue date Jan 30, 2006
Posted date Jan 30, 2006
Issuing office Seattle District Office
Product type Devices
CFR sections cited 820, 807.81(b), 820.40
Country 3
Inspection city Fall City
Inspection ZIP 98024-9714
Inspection start date Aug 17, 2005
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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