FDA WARNING_LETTER - Hospira Australia Pty Ltd. - March 01, 2014

On September 26, 2014, the FDA issued a Warning Letter to Hospira Australia Pty, Limited, following an inspection from February 24 to March 1, 2014. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations included: 1. **Inadequate investigation of OOS results (21 CFR 211.192):** * Failure to thoroughly investigate out-of-specification (OOS) results for an impurity in multiple batches of an injection product, despite recurring OOS values and concerns about vial-to-vial variability. The firm's investigations were deemed insufficient, and the practice of averaging individual OOS impurity values was questioned. * Failure to implement effective corrective and preventive actions for recurrent foreign matter (particles) in an injection drug product, despite investigations spanning from 2012 to 2014. No validated analytical method was established to detect these particles.

2. **Failure to establish adequate production and process controls (21 CFR 211.100(a)):** * Concerns regarding the validation of the manufacturing process related to