Form FDA 483 · Issued 2025-11-26
Baxalta US Inc. — FDA Form 483 Analysis
FEI: 3012385969 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Plasma Derivative Manufacturer) · Lead Investigator: Rebecca M. Okafor
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.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.101(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Component addition checked by 2nd person
Inspector Observation Language: "Each component is not added to a batch by one person and verified by a second person. Specifically, observed during inspection of Baxalta US Inc. on 2025-11-26."
Plain-English Meaning: 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.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.42(c)(7)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Quarantined Drug Products Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release. Specifically, observed during inspection of Baxalta US Inc. on 2025-11-26."
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 #3 · 21 CFR 211.130(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Lot or control number assigned
Inspector Observation Language: "The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. Specifically, observed during inspection of Baxalta US Inc. on 2025-11-26."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #4 · 21 CFR 211.134(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Correct labels during finishing operations
Inspector Observation Language: "Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. Specifically, observed during inspection of Baxalta US Inc. on 2025-11-26."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.