FDA WARNING_LETTER - ID Biomedical Corp., a subsidary of GSK Biologicals - April 09, 2014

On June 12, 2014, the FDA issued a Warning Letter to ID Biomedical Corporation of Quebec d/b/a GlaxoSmithKline Biologicals (GSK) following an inspection from March 31 to April 9, 2014. The inspection revealed significant deviations from current good manufacturing practice (CGMP) requirements in the manufacture of their licensed biological drug product Flulaval and its intermediates, violating Section 501(a)(2)(B) of the FD&C Act, their BLA, and 21 CFR Parts 210 and 211.

Key violations include: 1. Failure to assure appropriate written procedures to prevent microbiological contamination of sterile drug products, specifically regarding validation of aseptic and sterilization processes (21 CFR 211.113(b)). An investigation initiated March 5, 2012, found out-of-trend (OOT) endotoxin results for Flulaval since May 2011. 2. Inadequate controls for the purified water system, leading to bioburden and endotoxin excursions. The 2012 and 2013 Annual Product Quality Review reports indicated numerous bioburden excursions in water system Loop (b)(4), with organisms like *Ralstonia pickettii* and *Achromobacter spp.* identified. *Achromobacter xylosoxidans*, a water-borne