FDA WARNING_LETTER - SmithKline Beecham (Cork) Ltd. - October 23, 2013

This FDA Warning Letter, dated March 18, 2014, was issued to SmithKline Beecham (Cork) Ltd. following an inspection from October 18-23, 2013. The inspection identified deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering the APIs adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to fully investigate critical deviations:** The firm discovered in January 2012 that the (b)(4) used to manufacture (b)(4) batches of (b)(4) and (b)(4) batches of (b)(4) was contaminated with pharmaceutical waste. Despite this, (b)(4) shipments of potentially contaminated (b)(4) batches were distributed. The firm's quality assessments for (b)(4) and (b)(4) differed, with (b)(4) relying on additional testing showing significant contamination, while (b)(4) relied on standard release testing that may have been inadequate. The firm failed to notify customers of this significant deviation. 2. **Failure to investigate and document out-of-specification results:** In September and October 2011, solvent from the (b)(4) tank showed unexpected peaks in chromatograms, indicating contamination, but laboratory personnel ignored these,