FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - April 21, 2021

This FDA Form 483 was issued to Mark J. Kuenzi, Vice President, Quality Operations, at Fujifilm Diosynth Biotechnologies USA, Inc., a drug substance manufacturer located at 101 J Morris Commons Ln, Morrisville, NC 27560 (FEI Number: 3000718852). The inspection occurred from April 14, 2021, to April 21, 2021.

The inspection revealed five key observations:

1. **Lack of Comprehensive Risk Assessments for Cross-Contamination:** The facility lacks comprehensive risk assessments to justify containment strategies and controls for preventing cross-contamination between microbial and cell culture processes, especially with shared product contact equipment. Specific issues include undocumented formal risk assessments for shared equipment, no formal risk assessment for potential viral cross-contamination in shared downstream purification areas, inconsistent product classification for cleaning (Band C vs. Band D), and scientifically unjustified PDE determination for a Band D product.

2. **Inadequate Manufacturing Process Monitoring and Control:** The manufacturing process is not adequately monitored or controlled. This includes unrecorded or unmonitored product temperatures during intermediate holds, observed discoloration in shared equipment with an unknown source and no visual assessment procedures, a crevice observed in shared equipment with no visual assessment procedures, and unrecorded installation of an additional valve in the batch record for a unit operation.

3. **Non-Adherence