Warning letter

AmeriWater, Inc.: warning letter of Apr 10, 2007

FDA warning letter UCM076353 · Cincinnati District Office

Key facts

Reference number UCM076353
Company AmeriWater, Inc.
Subject Premarket Approval/Misbranded/Adulterated
Issue date Apr 10, 2007
Posted date Apr 10, 2007
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 807.81(b)
Country 3
Inspection city Dayton
Inspection ZIP 45414-3425
Inspection start date Nov 7, 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:

Browse all FDA warning letters