FDA 483 - AquaScience Technologies & Research Inc. - February 19, 2019

AquaScience Technologies & Research Inc. in Richmond, MO, a drug manufacturer, was cited for significant deficiencies in quality control during an FDA inspection. Observations included failures in product testing and release, inadequate investigation of out-of-specification results, poor documentation practices, and insufficient control over labeling materials. These issues indicate a lack of adherence to good manufacturing practices, potentially impacting product quality and traceability.