Warning letter

Noble Anesthesia-Air, Inc.: warning letter of Sep 12, 2012

FDA warning letter 328578 · Florida District Office

Key facts

Reference number 328578
Company Noble Anesthesia-Air, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Sep 12, 2012
Posted date Sep 12, 2012
Issuing office Florida District Office
Product type Devices
CFR sections cited 803, 803.3, 803.17, 807.81, 820, 803.50(b)
Inspection city Gainesville
Inspection ZIP 32609
Inspection start date Jun 19, 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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