FDA 483 - SmartScience Laboratories, Inc. - December 10, 2018

SmartScience Laboratories, Inc. in Tampa, FL, was inspected by the FDA, resulting in six observations related to significant deficiencies in their manufacturing and quality control processes. The inspection revealed issues including a lack of stability testing programs, improper handling and storage of drug components, inadequate contamination prevention during manufacturing, and failures in equipment cleaning and documentation procedures. These findings indicate a general lack of adherence to Good Manufacturing Practices, posing potential risks to product quality and safety.