Warning letter

General Hearing Instruments Inc: warning letter of Sep 18, 2013

FDA warning letter UCM379853 · New Orleans District Office

Key facts

Reference number UCM379853
Company General Hearing Instruments Inc
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Sep 18, 2013
Posted date Sep 18, 2013
Issuing office New Orleans District Office
Product type Devices
CFR sections cited 803.17, 820
Country 3
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited

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:

Browse all FDA warning letters