Warning letter

North Texas IRB: warning letter of Apr 14, 2003

FDA warning letter UCM147431 · Center for Biologics Evaluation and Research

Key facts

Reference number UCM147431
Company North Texas IRB
Subject Institutional Review Board
Issue date Apr 14, 2003
Posted date Apr 14, 2003
Issuing office Center for Biologics Evaluation and Research
Product type Devices
CFR sections cited 50.25, 56, 56.109, 56.111, 56.115, 56.120, 50, 56.106(a), 56.107(e), 56.108(a), 56.115(b), 56.120(b)(1) and 3 more
Country 3
Letter on fda.gov web.archive.org

At a glance

  • 10–99 CFR sections cited

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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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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