SmithKline Beecham Limited – FDA Warning Letter

On October 7, 2011, the FDA issued a Warning Letter to SmithKline Beecham Limited following a March 2011 inspection of their Worthing, UK pharmaceutical manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's April 7, 2011 response was deemed insufficient.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR § 211.113(b)):** * Disinfectant qualification for (b)(4) and (b)(4) bi-spore disinfectants failed to meet log reduction criteria against multiple organisms on various surfaces, yet continued to be used. * SOP PMC6169 ("Aseptic & Support Area Sanitization Following Maintenance Shutdown") was inadequate; a January 2011 media fill resulted in two contaminated units, attributed to stopper bags left in the Class 100 area during shutdown, without sufficient supporting data. The SOP also lacked requirements for material removal during shutdowns. * Personnel gown monitoring was inadequate, conducted on a (b)(4) basis, sampling only hood, goggles, and sleeves, despite operators performing substantial interventions. An operator was observed sanitizing hands directly over an air viable microbial plate,