Form FDA 483 · Issued 2026-02-24
RayzeBio, Inc — FDA Form 483 Analysis
FEI: 3030530655 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to RayzeBio, Inc (FEI 3030530655) on 2026-02-24 following an inspection of its manufacturer operations in Indiana. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Lack of/inadequate, environmental monitoring
Inspector Observation Language: "[Lack of] [Inadequate] routine environmental monitoring in the [ISO 5 area] [classified areas]. Specifically, observed during inspection of RayzeBio, Inc on 2026-02-24."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #2 · 21 CFR 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Backup file not maintained
Inspector Observation Language: "Failure to maintain a backup file of data entered into the computer or related system. Specifically, observed during inspection of RayzeBio, Inc on 2026-02-24."
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.