Warning letter

Hospira Costa Rica Ltd.: warning letter of Aug 22, 2012

FDA warning letter 331698 · Center for Devices and Radiological Health

Key facts

Reference number 331698
Company Hospira Costa Rica Ltd.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Aug 22, 2012
Posted date Aug 22, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Heredia
Inspection start date Apr 16, 2012
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:

Browse all FDA warning letters