> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 10 Observations on Fujifilm Diosynth FDA-483
- URL: https://www.fdaweb.com/10-observations-on-fujifilm-diosynth-fda-483/
- Published: 2021-08-26T12:00:00.000Z
- Updated: 2026-09-14T17:11:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150026

FDA has released the FDA-483 with 10 observations issued following a 4/14-4/21 inspection at Fujifilm Diosynth Biotechnologies USA, a Morrisville, NC, drug substance manufacturer. The observations were: 

- there are no comprehensive risk assessments conducted at this multi-product facility to justify the containment strategy and controls of manufacturing redacted products using microbial and cell culture processes to prevent cross-contamination;
- a redacted manufacturing process is not adequately monitored and/or controlled to ensure the quality of a drug substance is not adversely affected;
- procedures of material management systems are not followed or are inadequate;
- failing to establish adequate cleaning and sanitization procedures for non-dedicated product contact equipment at the multi-product manufacturing facility to prevent cross-contamination;
- discrepancies are not fully investigated to identify a root cause and corrective and preventive activities are not adequately implemented to prevent a recurrence;
- microbial control of the facility is inadequate;
- a redacted microbial hold time study was not adequately conducted;
- written procedures are not followed by manufacturing employees;
- failing to establish procedural controls for electronic data acquisition systems to ensure that data records are protected from unauthorized manipulation; and
- manufacturing areas and equipment in the facility are not adequately designed, maintained, and labeled.