Warning letter

Sibley Memorial Hospital [ARCHIVED]: warning letter of Dec 15, 2009

FDA warning letter 88104 · Baltimore District Office

Key facts

Reference number 88104
Company Sibley Memorial Hospital [ARCHIVED]
Subject CGMP for Blood & Blood Products/Adulterated
Issue date Dec 15, 2009
Posted date Dec 15, 2009
Issuing office Baltimore District Office
Product type Biologics
CFR sections cited 606.160, 606.65(e), 606.100(c), 606.171(a), 606.171(b), 610.47(b)(3), 606.100(b)
Inspection city Washington
Inspection ZIP 20016
Inspection start date Sep 14, 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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