FDA 483 - Synergy Health AST, LLC - June 06, 2025

During an inspection from June 3-6, 2025, the FDA cited Synergy Health AST, LLC in Petaluma, CA, for failing to thoroughly review unexplained discrepancies. Specifically, the firm did not reevaluate an irradiated drug product lot after a significant temperature excursion in storage, leading to its distribution without proper disposition in records. This indicates a critical lapse in quality control and batch release procedures.