FDA EIR - FUJIFILM Diosynth Biotechnologies Texas, LLC - August 31, 2021

An FDA Level 1 GMP inspection of Fujifilm Diosynth Biotechnologies Texas LLC was conducted from August 23 to August 31, 2021, at their College Station, TX facility. The inspection, performed under Compliance Program 7345.848, focused on the contract manufacturing of biological bulk drug substances, covering Quality, Production, Facilities & Equipment, and Laboratory systems. The company received a FORM FDA-483 documenting nine objectionable conditions.

Main violations included a lack of written procedures for personnel movement between virus-positive and negative environments, an inadequate investigation into an upstream batch contamination, and insufficient quantitative measurements for equipment qualification. Other issues were the absence of testing for materials used in buffer preparation, unaddressed data integrity for manufacturing and QC lab instrumentation, and a lack of identity testing for cell and virus banks. Furthermore, inadequately labeled warehouse locations, inaccurate digital inventory records, and a failure to review or trend work orders to assess preventative maintenance or equipment requalification needs were observed. The firm also had missing and unassigned required training records for manufacturing employees. Management was informed to submit a written response detailing voluntary corrective actions to the FDA.