Warning letter

Hospira Spa: warning letter of Mar 31, 2015

FDA warning letter 439066 · Center for Drug Evaluation and Research

Key facts

Reference number 439066
Company Hospira Spa
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Mar 31, 2015
Posted date Apr 6, 2015
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 211.192, 211.68(b), 211.113(b), 211.194(a)
Inspection city Liscate
Inspection start date May 5, 2014
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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