Warning letter

Brookwood Medical Center [ARCHIVED]: warning letter of Apr 22, 2010

FDA warning letter 98185 · Center for Drug Evaluation and Research

Key facts

Reference number 98185
Company Brookwood Medical Center [ARCHIVED]
Subject Institutional Review Board (IRB)
Issue date Apr 22, 2010
Posted date Apr 22, 2010
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 56.108(a)(4), 56.111(a)(1), 56.108(c)
Inspection city Birmingham
Inspection ZIP 35209
Inspection start date Nov 9, 2009
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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