Baxalta US Inc.
Registered Address: Illinois, United States of America (USA) (United States of America (USA))
5 Questions to Ask Baxalta US Inc. 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 2025-11-26, FDA cited 21 CFR 211.42(d) (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 2025-11-26, FDA cited 21 CFR 211.42(c)(4) (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 2025-11-26, FDA cited 21 CFR 211.122(b) (Finished Product Testing, Stability & Expiration Dating). 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 3012385969?
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 Baxalta US Inc. (FEI 3012385969) on 2025-11-26 following an inspection of its manufacturer operations in Illinois. The report documents 3 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
- 21 CFR 211.42(d) (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 211.42(c)(4) (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 211.122(b) (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. REPEAT OBSERVATION
FDA Form 483 issued to Baxalta US Inc. (FEI 3012385969) on 2025-11-26 following an inspection of its plasma derivative manufacturer operations in Illinois. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
- 21 CFR 211.101(d) (Incoming Ingredient Identity Testing & COA Qualification): 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.
- 21 CFR 211.42(c)(7) (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 211.130(c) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
- 21 CFR 211.134(a) (Label Control, Undeclared Allergens & Structure/Function Claims): Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
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) | 2025-11-26 | -8.1 pts | INSP-483-3012385969-20251126 ↗ |
| Inspection Outcome (VAI) | 2025-11-26 | -8.1 pts | INSP-483-1000519965-20251126 ↗ |
| Form 483 (3 observations, 1 repeat) | 2025-11-26 | -9.7 pts | 483-3012385969-20251126 ↗ |
| Form 483 (4 observations, 1 repeat) | 2025-11-26 | -12.1 pts | 483-1000519965-20251126 ↗ |