FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - May 01, 2015

An FDA inspection of Fujifilm Diosynth Biotechnologies in Research Triangle Park, NC, identified significant issues across its drug substance manufacturing, laboratory controls, and quality systems. Deficiencies included recurring filter clogging, inadequately established process parameters, and discrepancies between manufacturing processes and documentation. The firm also failed to conduct thorough investigations into bioburden excursions and total organic carbon increases, highlighting a lack of robust quality oversight and control.