FDA WARNING_LETTER - Commonwealth Serum Laboratories (CSL), Ltd. - March 31, 2011

The FDA issued a Warning Letter to CSL Biotherapies following an inspection from March 21-31, 2011, at their Parkville, Australia facility. The inspection documented deviations from current Good Manufacturing Practice (CGMP) requirements for licensed biological vaccine Afluria and monovalent influenza bulks, violating Sections 501(a)(2)(B) of the FD&C Act, 351(a) of the PHS Act, and 21 CFR Parts 210, 211, and 600-680.

Significant deviations included: 1. **Inadequate Investigations:** Failure to thoroughly investigate unexplained discrepancies or batch failures. Examples cited were an insufficient investigation into Afluria adverse events (fever/convulsions in children), lacking documentation, limited manufacturing process analysis, and no testing for (b)(4) content differences. Also, an inadequate investigation into dark particles in thimerosal-containing multi-dose vials, focusing only on multi-dose vials without sufficient rationale. 2. **Production and Process Control Deficiencies:** Failure to establish and follow written controls, such as not determining optimal splitting conditions for new virus strains (e.g., A/Victoria/210/2009) before production, and not reviewing Haemagglutinin Antigen (HA) presence in (b)(4) seasonally. 3. **Inadequate Failure