Warning letter

Jamaica Hospital Medical Center IRB: warning letter of Feb 24, 2016

FDA warning letter 486430 · Center for Drug Evaluation and Research

Key facts

Reference number 486430
Company Jamaica Hospital Medical Center IRB
Subject Institutional Review Board (IRB)
Issue date Feb 24, 2016
Posted date Mar 8, 2016
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 56.115(a)(5), 56.115(a)(2)
Inspection city Jamaica
Inspection ZIP 11418
Inspection start date Aug 13, 2015
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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