FDA WARNING_LETTER - Hospira Inc. - February 07, 2013

The FDA issued a Warning Letter to Hospira, Inc. following an inspection from January 29 to February 7, 2013, which identified significant violations of the Quality System (QS) Regulation for medical devices. The inspected devices included Class II infusion systems: GemStar, Plum A+, LifeCare PCA, and Symbiq. These devices were deemed adulterated due to non-conformity with current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 820).

Key violations include: - **Design Controls (21 CFR 820.30):** Failure to establish adequate procedures for design requirements (e.g., Plum A+ battery specifications), design verification (battery life expectancy), design validation (risk analysis for GemStar overdose issue), and updating design and development plans (GemStar Rollback project). Hospira's responses were deemed inadequate, lacking interim actions for in-market Plum A+ pumps and sufficient documentation. - **Corrective and Preventive Action (CAPA) (21 CFR 820.100):** Inadequate CAPA system implementation, including failure to trend component failures (Plum A+ APP board, San Jose repair site data), implement identified corrective actions for battery failures (CAPA 200900000000000000000000000000000000