Warning letter

AmeriWater Inc.: warning letter of Oct 6, 2000

FDA warning letter UCM068919 · Cincinnati District Office

Key facts

Reference number UCM068919
Company AmeriWater Inc.
Subject Quality System Regulation/Adultered/Misbranded
Issue date Oct 6, 2000
Posted date Oct 6, 2000
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 320, 803, 803.50, 803.18(b), 803.50(a)(2), 803.50(b)(2), 803.18, 820, 820.3, 803.50(b)
Country 3
Inspection city Dayton
Inspection ZIP 45414-3425
Inspection start date Jun 20, 2000
Letter on fda.gov web.archive.org

At a glance

  • 10–99 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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