FDA 483 - Wyeth Farma SA - November 22, 2024

Wyeth Farma SA, a biological drug manufacturer in San Sebastian De Los Reyes, Madrid, Spain, was cited with two observations during an FDA inspection. The firm's aseptic process simulations for sterile drug products were found to not represent worst-case manufacturing conditions, including issues with batch sizes and operator challenges, and one simulation failed due to contamination. Additionally, the firm failed to thoroughly review unexplained discrepancies, specifically regarding a lyophilizer load incident and non-compliance with product storage conditions, and did not implement a formal CAPA for identified human error.