Warning letter

LifeServe Blood Center: warning letter of Aug 9, 2013

FDA warning letter 407983 · Kansas City District Office

Key facts

Reference number 407983
Company LifeServe Blood Center
Subject CGMP Blood & Blood Components/Adulterated
Issue date Aug 9, 2013
Posted date Aug 9, 2013
Issuing office Kansas City District Office
Product type Biologics
CFR sections cited 610.40(h)(1), 606, 606.160(a), 610.40(a), 610.40(b), 610.41(a)
Inspection city Johnston
Inspection ZIP 50131
Inspection start date Jun 13, 2013
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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