# FDA WARNING_LETTER - Hospira Costa Rica Ltd. - April 19, 2012

Source: https://www.keypedia.com/records/warning_letter/hospira-costa-rica-ltd/cab7f31d-8814-4136-8d4e-fdb3d1b91827

> FDA WARNING_LETTER for Hospira Costa Rica Ltd. on April 19, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hospira Costa Rica Ltd.
- Inspection Date: 2012-04-19
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On August 22, 2012, the FDA issued a Warning Letter to Hospira, Inc. following an inspection of their Costa Rica facility from April 16-19, 2012. The inspection revealed that Hospira's Symbiq, Plum, Gemstar, and Lifecare PCA infusion pumps and intravascular administration sets were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Key violations included:
1.  **Failure to identify corrective and preventive actions (21 CFR 820.100(a)(3)):** Despite a February 2011 recall for Plum pump audible alarm failures and a supplier corrective action, multiple complaints of no audible alarms persisted in March 2012.
2.  **Failure to implement and record changes for quality problems (21 CFR 820.100(a)(5)):**
    *   An obsolete instruction remained in a procedure (502-95004-006) related to a September 2011 recall (Z-3284-2011) for unrestricted free-flow in Plum pumps.
    *   A required visual inspection for regulator closure installation, a corrective action for recall Z-

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- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/hospira-costa-rica-ltd/1c52f386-e443-4e08-82ed-cb84cf7aa8a2

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7