1Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing and packing.
Inspection Record
Dendreon Pharmaceuticals LLC — FDA 483 Findings
Inspectors Sony Mathews · Esther A Ofori · Lizaida Perez and 1 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
4Other quality system
Drug product (b) (4) are (b) (4) so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
5Quality unit oversight
Reprocessing was performed without the review and approval of the quality control unit.
6Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
7Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
8Laboratory and QC controls
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
9Other quality system
Employees engaged in the manufacture, processing and packing of a drug product lack the experience required to perform their assigned functions.
About this record
Extracted automatically from the document US FDA published on 2026-10-19. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
