Warning letter

Staar Surgical Co.: warning letter of May 21, 2014

FDA warning letter 424426 · Los Angeles District Office

Key facts

Reference number 424426
Company Staar Surgical Co.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date May 21, 2014
Posted date May 21, 2014
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 820
Inspection city Monrovia
Inspection ZIP 91016
Inspection start date Feb 10, 2014
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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