FDA 483 - SmartScience Laboratories, Inc. - November 22, 2024

SmartScience Laboratories, Inc. in Tampa, FL, a pharmaceutical contract manufacturer/repacker, was cited for numerous significant deficiencies during an FDA inspection from 11/18/2024 to 11/22/2024. The observations highlight severe issues across data integrity, quality control oversight, personnel qualification, manufacturing processes, laboratory controls, stability testing, and facility sanitation. These findings indicate a widespread lack of control and adherence to cGMP regulations, posing potential risks to drug product quality and patient safety.