Form FDA 483 · Issued 2025-10-29
Dendreon Pharmaceuticals LLC — FDA Form 483 Analysis
FEI: 3008914686 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Cell and Gene Therapy) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Dendreon Pharmaceuticals LLC (FEI 3008914686) on 2025-10-29 following an inspection of its cell and gene therapy operations in Massachusetts. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Master Manufacturing & Batch Production Records (MMR/BPR).
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 3 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.184(c)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Individual inventory record
Inspector Observation Language: "Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated batch or lot of drug product. Specifically, observed during inspection of Dendreon Pharmaceuticals LLC on 2025-10-29."
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.
Observation #2 · 21 CFR 211.188(b)(13)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Results of drug product inspections and examinations
Inspector Observation Language: "The batch production and control records are deficient in that they do not include results of drug product [examinations] [inspections]. Specifically, observed during inspection of Dendreon Pharmaceuticals LLC on 2025-10-29."
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 · 21 CFR 211.194(a)(8)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Identification of Person Performing Review of Lab Records
Inspector Observation Language: "Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy. Specifically, observed during inspection of Dendreon Pharmaceuticals LLC on 2025-10-29."
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.