FDA 483 - Glaxo Operations UK Limited - September 06, 2019

During an inspection of Glaxo Operations UK Limited in Ware, Hertfordshire, the FDA observed a lack of established procedures to prevent objectionable microorganisms in non-sterile drug products. Specifically, there was no sanitization of critical water supply loops feeding manufacturing and active pharmaceutical ingredient suites. This indicates a significant concern regarding microbial control within the facility's production environment.