FDA 483 - Whisk Products Inc - October 22, 2021

Whisk Products Inc. in Wentzville, MO, was inspected and cited for significant deficiencies across its quality control and manufacturing processes. The firm failed to conduct thorough investigations into discrepancies, lacked validated microbial testing methods and proper stability monitoring, and exhibited poor data integrity practices. These issues indicate a systemic lack of adherence to GMP regulations, posing risks to drug product quality and patient safety.