FDA WARNING_LETTER - Hospira Spa - May 13, 2014

This FDA Warning Letter, dated March 31, 2015, was issued to Hospira S.p.A. following a May 2014 inspection of their Liscate, Italy, pharmaceutical manufacturing facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** Inadequate dynamic airflow studies (smoke studies) failed to evaluate critical aseptic interventions and demonstrate unidirectional airflow, potentially compromising product sterility. The firm also improperly rejected integral units from media fills without justification. These issues were similar to those found at their India facility in 2012. 2. **Inadequate investigation of discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate 103 complaints of discoloration in a drug product, inadequately assessing the impact of degradation and potential manufacturing process vulnerabilities. 3. **Insufficient computer system controls (21 CFR 211.68(b)):** HPLC and GC data acquisition software lacked controls to prevent deletion or alteration of raw data, with no audit trail function enabled for a "Test" folder where data was deleted and overwritten. This mirrors a finding at their India facility in 20