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# 8 Observations on Fujifilm Diosynth FDA-483
- URL: https://www.fdaweb.com/8-observations-on-fujifilm-diosynth-fda-483/
- Published: 2026-04-29T12:00:00.000Z
- Updated: 2026-09-14T13:38:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161067

FDA has released the form [FDA-483](https://www.fda.gov/media/192222/download?ref=fdaweb.com) issued following a 3/4-3/11/2025 inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in College Station, TX. The eight inspection observations were:

- failure to adequately control the multi-product manufacturing areas to prevent potential cross-contamination;
- the quality control laboratory controls used for in-process, release, and stability testing of a redacted intermediate do not include appropriate testing procedures that assure conformance to appropriate standards of quality and purity;
- failure to follow a specific stability testing program;
- the cleaning and sanitization program is deficient in preventing potential contamination in the controlled drug substance manufacturing areas.
- environmental monitoring of classified processing areas in the redacted facility for the redacted intermediate manufacturing is deficient;
- failure to exercise appropriate controls for the electronic data acquisition systems used for redacted intermediate manufacturing;
- SOPs or work instructions are not followed or are inadequate; and
- the intermediate hold times defined in the redacted intermediate batch records are inconsistent with the hold times defined in a redacted document.