Warning letter

Baptist Medical Center [ARCHIVED]: warning letter of May 14, 2009

FDA warning letter 49039 · Dallas District Office

Key facts

Reference number 49039
Company Baptist Medical Center [ARCHIVED]
Subject CGMP for Blood & Blood Components/Adulterated
Issue date May 14, 2009
Posted date May 14, 2009
Issuing office Dallas District Office
Product type Biologics
CFR sections cited 606.60(a), 606.100(b)(8), 606.100(c), 606.140(c), 606.100(b)
Inspection city San Antonio
Inspection ZIP 78205
Inspection start date Mar 23, 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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