Warning letter

Winspan, Inc.: warning letter of Jun 27, 2006

FDA warning letter UCM075959 · Los Angeles District Office

Key facts

Reference number UCM075959
Company Winspan, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jun 27, 2006
Posted date Jun 27, 2006
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 801.109, 803.17, 868, 868.5915, 807.81(a)(3)(ii), 820, 807.81(b)
Country 3
Inspection city San Fernando
Inspection ZIP 91340-2233
Inspection start date Jan 26, 2006
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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