Form FDA 483 · Issued 2026-03-27
Fujifilm Diosynth Biotechnologies USA Inc. — FDA Form 483 Analysis
FEI: 3000718852 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Substance Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Fujifilm Diosynth Biotechnologies USA Inc. (FEI 3000718852) on 2026-03-27 following an inspection of its drug substance manufacturer operations in North Carolina. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.84(d)(1)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Component identity verification
Inspector Observation Language: "Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. Specifically,observed during inspection of Fujifilm Diosynth Biotechnologies USA Inc. on 2026-03-27."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
input/output verification
Inspector Observation Language: "Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, observed during inspection of Fujifilm Diosynth Biotechnologies USA Inc. on 2026-03-27."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.