Warning letter

United Contact Lens, Inc.: warning letter of Nov 30, 2016

FDA warning letter 510092 · Seattle District Office

Key facts

Reference number 510092
Company United Contact Lens, Inc.
Subject CGMP/Medical Devices Reporting/Adulterated/Misbranded
Issue date Nov 30, 2016
Posted date Dec 13, 2016
Issuing office Seattle District Office
Product type Devices
CFR sections cited 803, 803.17, 820
Inspection city Arlington
Inspection ZIP 98223
Inspection start date Oct 4, 2016
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