Form FDA 483 · Issued 2026-02-06
CSL Plasma Inc — FDA Form 483 Analysis
FEI: 3022099864 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Plasmapheresis Center) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to CSL Plasma Inc (FEI 3022099864) on 2026-02-06 following an inspection of its plasmapheresis center operations in Pennsylvania. The report documents 2 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Label Control, Undeclared Allergens & Structure/Function Claims.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 2 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.105(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
REPEAT CITATION AT FACILITY
Distinctive ID or code not recorded in batch record
Inspector Observation Language: "The batch records do not record the distinctive [identification number] [code] [name of equipment] to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. Specifically, observed during inspection of CSL Plasma Inc on 2026-02-06."
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 #2 · 21 CFR 211.122(d)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Labels and labeling stored separately
Inspector Observation Language: "Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents. Specifically, observed during inspection of CSL Plasma Inc on 2026-02-06."
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.