Form FDA 483 · Issued 2025-11-21
Wacker Biotech B.V. — FDA Form 483 Analysis
FEI: 3008539577 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Substance Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Wacker Biotech B.V. (FEI 3008539577) on 2025-11-21 following an inspection of its drug substance manufacturer operations in Netherlands. The report documents 2 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Label Control, Undeclared Allergens & Structure/Function Claims.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.130(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
REPEAT CITATION AT FACILITY
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 Wacker Biotech B.V. on 2025-11-21."
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 211.134(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 Wacker Biotech B.V. on 2025-11-21."
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.