Warning letter

Rebuilder Medical, Inc. [ARCHIVED]: warning letter of Mar 8, 2011

FDA warning letter 167912 · Baltimore District Office

Key facts

Reference number 167912
Company Rebuilder Medical, Inc. [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Mar 8, 2011
Posted date Mar 8, 2011
Issuing office Baltimore District Office
Product type Devices
CFR sections cited 820
Inspection city Charles Town
Inspection ZIP 25414
Inspection start date Jan 4, 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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