Form FDA 483 · Issued 2026-03-25
Dendreon Pharmaceuticals LLC — FDA Form 483 Analysis
FEI: 3008821247 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Biological Drug Manufacturer) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Dendreon Pharmaceuticals LLC (FEI 3008821247) on 2026-03-25 following an inspection of its biological drug manufacturer operations in California. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.103
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Actual vs. theoretical yields not determined
Inspector Observation Language: "Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product. Specifically, observed during inspection of Dendreon Pharmaceuticals LLC on 2026-03-25."
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 211.100(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Procedure Deviations Recorded and Justified
Inspector Observation Language: "Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, observed during inspection of Dendreon Pharmaceuticals LLC on 2026-03-25."
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 #3 · FDCA 582(b)(4)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Systems in place to comply with verification requirements
Inspector Observation Language: "Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA. Specifically, observed during inspection of Dendreon Pharmaceuticals LLC on 2026-03-25."
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 #4 · 21 CFR 211.84(b)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Representative Samples
Inspector Observation Language: "Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, observed during inspection of Dendreon Pharmaceuticals LLC on 2026-03-25."
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.