FDA 483 - SOFIE Co. dba SOFIE - January 20, 2023

An FDA inspection of SOFIE Co. dba SOFIE, a PET manufacturer in Somerset, NJ, revealed significant deficiencies across its quality system, production, laboratory controls, and facilities. Observations included widespread failure to follow written quality assurance procedures, inadequate investigations into deviations and out-of-specification results, and insufficient controls to ensure product quality and sterility. The firm also failed to properly handle complaints, validate test procedures, and maintain equipment suitability and cleanliness.