FDA 483 - SUNNY PHARMTECH INC. - September 29, 2022

SUNNY PHARMTECH INC, a drug and API manufacturer in Taoyuan City, Taiwan, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination in sterile and non-sterile drug products, failures in quality control unit responsibilities, and a lack of adherence to written production and process control procedures. These issues indicate a systemic breakdown in maintaining a state of control over manufacturing processes and quality systems.