FDA 483 - NuGeneration Technologies, LLC - September 22, 2022

An FDA inspection of NuGeneration Technologies, LLC in Emeryville, CA, revealed significant deficiencies in their drug manufacturing operations. The firm failed to establish and follow adequate quality control procedures, conduct proper investigations into discrepancies, and perform essential testing for their NuRinse Hand Sanitizer product. These issues indicate a broad lack of adherence to current Good Manufacturing Practices.