Warning letter

Ophthalmic International: warning letter of Feb 12, 1998

FDA warning letter UCM066281 · Los Angeles District Office

Key facts

Reference number UCM066281
Company Ophthalmic International
Subject Premarket Approval Application [PMA]
Issue date Feb 12, 1998
Posted date Feb 12, 1998
Issuing office Los Angeles District Office
Product type Unknown
CFR sections cited 812.20, 807.81(a)(3)(i), 812.7(a), 807.81(a), 812.20(a)
Country 3
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited

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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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