FDA 483 - GlaxoSmithKline LLC - March 18, 2016

An FDA inspection of GlaxoSmithKline LLC's non-clinical laboratory in King Of Prussia, PA, revealed significant deficiencies in their quality assurance unit. The firm failed to ensure proper authorization and documentation for deviations from approved protocols and standard operating procedures. This included inadequate management review of training records, a lack of required email notifications for archived data, and insufficient record-keeping for archived record loans.