FDA 483 - Bloodworks - December 11, 2025

During an inspection from December 2-11, 2025, the FDA issued a Form 483 to Bloodworks in Seattle, WA, citing a significant lapse in their aseptic processing qualification program. The firm failed to perform required semi-annual media fills for cord blood manufacturing, directly violating their own written production and process control procedures. This indicates a critical deficiency in ensuring the sterility and quality of their products.