Form FDA 483 · Issued 2025-11-26
Baxalta US Inc. — FDA Form 483 Analysis
FEI: 3012385969 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Thomas W. Halvorsen
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.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.42(d)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Penicillin processing area not kept separate
Inspector Observation Language: "The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use. 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 #2 · 21 CFR 211.42(c)(4)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
In-Process Material Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials. 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 211.122(b)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Labeling and packaging improperly approved/released
Inspector Observation Language: "Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, observed during inspection of Baxalta US Inc. on 2025-11-26."
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.