Warning letter

Highland Laboratories, Inc.: warning letter of Oct 4, 2005

FDA warning letter UCM075593 · Seattle District Office

Key facts

Reference number UCM075593
Company Highland Laboratories, Inc.
Subject Lacks Approved New Drug Application
Issue date Oct 4, 2005
Posted date Oct 4, 2005
Issuing office Seattle District Office
Product type Drugs
Country 3
Inspection city Mount Angel
Inspection ZIP 97362-8910
Inspection start date Jun 29, 2005
Letter on fda.gov web.archive.org

At a glance

  • 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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