Form FDA 483 · Issued 2026-03-12
Corixa Corporation — FDA Form 483 Analysis
FEI: 3007726770 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Corixa Corporation (FEI 3007726770) on 2026-03-12 following an inspection of its drug manufacturer operations in Pennsylvania. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 314.80(c)(2)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Late submission of annual safety reports
Inspector Observation Language: "Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application. Specifically, observed during inspection of Corixa Corporation on 2026-03-12."
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 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Inadequate smoke studies
Inspector Observation Language: "Smoke studies [were not] [were inadequately] performed under dynamic conditions. Specifically, observed during inspection of Corixa Corporation on 2026-03-12."
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.