Form FDA 483 · Issued 2026-02-18
CSL Behring GmbH — FDA Form 483 Analysis
FEI: 3003098680 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Biological Drug Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to CSL Behring GmbH (FEI 3003098680) on 2026-02-18 following an inspection of its biological drug manufacturer operations in Germany. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.186(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written procedures followed
Inspector Observation Language: "Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, observed during inspection of CSL Behring GmbH on 2026-02-18."
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 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Acceptance of drug products
Inspector Observation Language: "Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products. Specifically, observed during inspection of CSL Behring GmbH on 2026-02-18."
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 · 21 CFR 211.188(b)(8)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Labeling control records including specimens or copies
Inspector Observation Language: "Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced. Specifically, observed during inspection of CSL Behring GmbH on 2026-02-18."
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 314.80(c)(2)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Late submission of quarterly safety reports
Inspector Observation Language: "Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. Specifically, observed during inspection of CSL Behring GmbH on 2026-02-18."
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 #5 · 21 CFR 212.20(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Determination need for investigation
Inspector Observation Language: "When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically, observed during inspection of CSL Behring GmbH on 2026-02-18."
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.