Warning letter

CooperVision, Inc. [ARCHIVED]: warning letter of Dec 5, 2011

FDA warning letter 252814 · New York District Office

Key facts

Reference number 252814
Company CooperVision, Inc. [ARCHIVED]
Subject CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
Issue date Dec 5, 2011
Posted date Dec 5, 2011
Issuing office New York District Office
Product type Devices
CFR sections cited 820
Inspection city West Henrietta
Inspection ZIP 14586
Inspection start date Oct 14, 2011
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:

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