Form FDA 483 · Issued 2025-12-16
WuXi Biologics Ireland Limited — FDA Form 483 Analysis
FEI: 3026506583 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Substance Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to WuXi Biologics Ireland Limited (FEI 3026506583) on 2025-12-16 following an inspection of its drug substance manufacturer operations in Ireland. The report documents 3 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 212.10
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Personnel not qualified
Inspector Observation Language: "You lack [a sufficient number of] personnel with the necessary [education] [background] [training] [experience] to perform their assigned functions. Specifically, observed during inspection of WuXi Biologics Ireland Limited on 2025-12-16."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 212.60(g)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Test records complete (general)
Inspector Observation Language: "Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays. Specifically,observed during inspection of WuXi Biologics Ireland Limited on 2025-12-16."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #3 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Contamination, production area/adjacent areas
Inspector Observation Language: "Contamination was observed in your [production area] [areas adjacent to production areas]. Specifically, observed during inspection of WuXi Biologics Ireland Limited on 2025-12-16."
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.