Warning letter

Bay Regional Medical Center IRB [ARCHIVED]: warning letter of Dec 20, 2011

FDA warning letter 242594 · Center for Drug Evaluation and Research

Key facts

Reference number 242594
Company Bay Regional Medical Center IRB [ARCHIVED]
Subject Institutional Review Board (IRB)
Issue date Dec 20, 2011
Posted date Dec 20, 2011
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 56.108(c), 56.110(b), 56, 56.120, 56.109(f), 56.110(d), 56.115(a)(2)
Inspection city Bay City
Inspection ZIP 48708
Inspection start date Jun 22, 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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