FDA 483 - Pharmaloop, S.L. - April 16, 2024

Pharmaloop, S.L. in Alcala de Henares, Spain, was inspected by the FDA from April 8-16, 2024, and received a Form 483 with two observations. The inspection revealed significant issues with preventing microbiological contamination in sterile drug products, including problems with environmental monitoring and aseptic filling processes. Additionally, the firm failed to adequately test raw materials used in drug product manufacturing.