Warning letter

Centra Health Inc IRB [ARCHIVED]: warning letter of Jun 13, 2011

FDA warning letter 178832 · Center for Devices and Radiological Health

Key facts

Reference number 178832
Company Centra Health Inc IRB [ARCHIVED]
Subject Institutional Review Board (IRB)
Issue date Jun 13, 2011
Posted date Jun 13, 2011
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 56.108, 56.108(a)(1), 56.108(b)(1), 56.109(f), 56.115(a)(6)
Inspection city Lynchburg
Inspection ZIP 24503
Inspection start date Feb 3, 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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