FDA 483 - Xellia Pharmaceuticals USA LLC - September 29, 2023

Xellia Pharmaceuticals USA LLC in Bedford, OH, a manufacturer of sterile drug products, received a Form 483 with two observations. The inspection revealed significant deficiencies in aseptic process validation, including unrepresentative media fills and inadequate smoke studies for Vancomycin production. Additionally, the firm failed to conduct thorough investigations into unexplained discrepancies, such as the source of a metal shard found in a Vancomycin batch.