FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - March 01, 2019

An FDA inspection of Fujifilm Diosynth Biotechnologies in Morrisville, NC, from February 25 to March 1, 2019, revealed two significant observations. The firm was cited for an inadequately validated bioburden testing method for PPQ batches and for inadequate investigation of deviations, including issues with TOC swab failures and exhaust air filter integrity testing.