FDA 483 - Celgene International Sarl - June 16, 2023

During an inspection, Celgene International Sarl in Boudry, Switzerland, was cited for inadequate cleaning and sanitization of equipment. Specifically, a parts washing station used for drug product containers was found to have components, such as O-rings and flanges, that were not adequately cleaned, posing a risk of cross-contamination and microbial growth to drug products. This observation highlights a significant concern regarding the firm's adherence to cGMP for equipment maintenance and sanitation.