Warning letter

ffrench Pocket Airway, Inc. [ARCHIVED]: warning letter of Jun 5, 2009

FDA warning letter 53923 · New Orleans District Office

Key facts

Reference number 53923
Company ffrench Pocket Airway, Inc. [ARCHIVED]
Subject Investigational Device Exemptions
Issue date Jun 5, 2009
Posted date Jun 5, 2009
Issuing office New Orleans District Office
Product type Devices
CFR sections cited 803, 803.17, 801.109(b)(1), 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b)(4), 807.81(a)(3)(ii), 820
Inspection city New Orleans
Inspection ZIP 70118
Inspection start date Jan 12, 2009
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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