FDA 483 - SSG Ventures - January 02, 2019

Scientific Solutions Global LLC, a drug manufacturer in Carle Place, NY, was inspected from December 2018 to January 2019. The inspection revealed significant deficiencies across its quality system, manufacturing processes, and control procedures, indicating a pervasive lack of fundamental GMP compliance. The firm failed to establish a quality control unit, perform product testing, validate processes, or maintain adequate records and employee training.