FDA 483 - Swiss American CDMO, LLC - March 31, 2022

An FDA inspection of Swiss-American CDMO, LLC in Carrollton, TX, revealed multiple significant deficiencies in their manufacturing operations. The firm failed to adhere to cGMP requirements, particularly concerning quality unit responsibilities, investigation of microbial contamination in water systems, and proper handling of complaints. Additional issues included inadequate employee training, unvalidated cleaning processes, uncontrolled storage conditions for drug products and raw materials, and poor material identification and segregation, indicating a systemic lack of quality oversight and control.