FDA 483 - Protherics UK Limited - June 23, 2022

Protherics UK Ltd., a manufacturer in Llandysul, Ceredigion, UK, was inspected by the FDA. The inspection revealed significant deficiencies in quality control testing procedures, including issues with endotoxin analysis, media comparison, and drug sample analysis. Additionally, the facility's qualification for (b)(4) testing and its environmental monitoring system for classified areas were found to be deficient.