Warning letter

Biomedical Research Institute of America d/b/a BioMed IRB: warning letter of Mar 29, 2012

FDA warning letter 278719 · Center for Biologics Evaluation and Research

Key facts

Reference number 278719
Company Biomedical Research Institute of America d/b/a BioMed IRB
Subject Institutional Review Board (IRB)
Issue date Mar 29, 2012
Posted date Mar 29, 2012
Issuing office Center for Biologics Evaluation and Research
Product type Biologics
CFR sections cited 56.107(f), 56.108(c), 56.115(a)(2), 56, 56.107, 56.111
Inspection city San Diego
Inspection ZIP 92108
Inspection start date Aug 8, 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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