WuXi Biologics Ireland Limited
Registered Address: Hungary (Hungary)
5 Questions to Ask WuXi Biologics Ireland Limited Before Signing a Manufacturing Contract
Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:
- Q1: On 2025-12-16, FDA cited 21 CFR 314.81(b)(1)(ii) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q2: On 2025-12-16, FDA cited 21 CFR 212.50(a) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q3: On 2025-12-16, FDA cited 21 CFR 212.71(b) (CAPA, Out-of-Specification (OOS) & Complaint Investigations). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
- Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3026506583?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
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 Hungary. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
- 21 CFR 314.81(b)(1)(ii) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window. REPEAT OBSERVATION
- 21 CFR 212.50(a) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
- 21 CFR 212.71(b) (CAPA, Out-of-Specification (OOS) & Complaint Investigations): Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
- FDCA 501(a)(2)(A) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
- FDCA 503B(b)(2)(A) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
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.
- 21 CFR 212.10 (Personnel GMP Training, Gowning & Hygienic Practices): Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
- 21 CFR 212.60(g) (Finished Product Testing, Stability & Expiration Dating): 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.
- FDCA 501(a)(2)(A) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Manufacturer Right-of-Reply & Free Match Correction
GUARDRAIL PROTECTEDTo ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
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Score Provenance Receipts
Every point in this facility's FDA Record Index (54/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2025-12-16 | -8.2 pts | INSP-483-3026506583-20251216 ↗ |
| Inspection Outcome (VAI) | 2025-12-16 | -8.2 pts | INSP-483-3026506583-20251216 ↗ |
| Form 483 (5 observations, 1 repeat) | 2025-12-16 | -14.7 pts | 483-3026506583-20251216 ↗ |
| Form 483 (3 observations, 0 repeat) | 2025-12-16 | -7.3 pts | 483-3026506583-20251216 ↗ |