DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD ANO DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER

Office ofCompliance and Biologics Quality, CBER, FDA

1401 Rockville Pike, HFM-676 

Rockville, MD 20852, Phone:301-827-303 I

16,2007 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: David Urda!, Ph.D., ChiefScientific Officer 

FIRM NAME 

Dendreon Corpration 

STREET ADDRESS

220 East Hanover Ave.

CITY. STATE AND ZIP CODE .

Morris Plains, NJ 07950 

TYPE OF ESTABLISHMENT INSPECTED

Cell Therapy Manufacturing Facility

THIS DOCUMENT LISTS OBSERVAllONS MADE BY THE FDA REPRESENlATIVE(S) DURING THE INSPECTION OF YOUR FACILITY. THEY 

REPRESENT 

ARE 

A FINAL 

INSPECTIONAL 

AGENCY 

OBSERVAllONS. 

DETERMINATION REGARDING 

ANO DO NOl

YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, 

IMPI.EI.ENT

OR 

. CORRECTIVE 

HAVE 

ACTION 

IMPLEMENTED, OR 

IN RESPONSE TO 

PLAN TO

OR 

AN OBSERVf\TION, YOU MAY OISCUSS THE OBJECTION OR f\CTION WilliTHE FDA 

SUBMIT THIS 

REPRESEMTATIVE(S) 

INFORMATION 

DURING THE 

TO FDA AT THE 

INSPECTION

ADDRESS ABOVE. IFYOU HAVE ANY QUESTIONS,PLEASE CONTACT FDA Al THE PHONE NUMBER ANO ADDRESS ABOVE. 

DURING AN INSPECTION.OF YOUR FIRM WE OBSERVED:

This was a pre-license inspection for sipuleucel-T, STN BL 125197/0.

. I. There are no data to support the concurrent manufacturing of. lots within a clean room module. Process Validation

Report QVDNo. 50999 includes data from only one day of concurrent manufacturing of- lots in Modulel and- lots

from a second day. The commercial process as described in the Biologics License Application (BLA) specifies the use of

- clean room modules, total o. workstations, per station. · · 

2. Insufficient personnel from the New Jersey manufacturing site were available to perform Aseptic Process Validation in

Modul (QVD No. 51000). A New Jersey contract employee with no previous training. in aseptic operations gowned in to

participate in the aseptic simulation to support this validation study. 

3. The quality control laboratory did not demonstrate adequate ability to maintain the chain of identity for the autologous

product. 

a No documented system is in place to track and manage the flow ofthe samples. There is also an inconsistent labeling

system to maintain the chain of identity ofthe samples. 

b The commercial system, as described in the BLA and presented during inspection, specifies the use of a bar code to

maintain identity. The QC laboratory does not have the capacity to read the barcode, nor is it connected to thedatabase used throughout the· rest of manufacturing. ln addition, infonnation sent from the QC laboratory to tl)e

manufacturing module does not contain a bar code. 

4. During Day OEr_Ocessing on Tuesday, February 13, 2007, we observed that lot number . being processed at step

in workstation I was resuspended in ; before being placed in theAccording to Technical Report 30366, the validated time for holding 

5. SOPs I I 058, Exception Reporting, and I I 059, Investigations, contain no time frame for closing out reports. 

6. Regarding SOP l0839, Change Control: 

a. There is no review of the Change Control Regulalory Impact Assessment (Fonn 60042) by the Regulatory Affairs

group. 

b. Form 60042 is used to document the Change Control Review Board {CCRB) decisions but this is not stated in the SOP.

7. Regarding SOP 10047, Supplier, Contractor, and Vendor Audits: 

EMPLOYEE(SJ NAME AND TlnE (Prinr or Type) DATE ISSUED

Mary P. Padgett, CSO February 16, 2007 

Gang Wang, Ph.D., Biologist 

Keith Wonnacott, Ph.D., Chief, Cellular

Therapy Branch 

Thomas P. Finn, Ph.D., Microbiologist

Helen B. Ricalde, CSO 

INSPECTIONAL OBSERVATIONS PAGE f of 2.PAGES 

/s/

SEE 

REVERSE 

OF THIS

PAGE 

EMPLOYEE(Sl SIGNATURE 

FORM FDA 483 (4/03} PREVIOUS EDITION OBSOLETE ( PSC M,d~ ... IJ'l ll '"· "''" EF) 
DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER

Office ofCompliance and Biologics Quality, CBER, FDA 16,2007

1401 Rockville Pike, HFM-676

Rockville, MD 20852, Phone:301-827-3031 

NAME AND TITI.E OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: David Urda!, Ph.D., Chief Scientific Officer 

FIRM NAME STREET ADDRESS

Dendreon Corpration 220 East Hanover Ave. 

CHY. STATE AND ZIP CODE TYPE OF ESTABLISHMENT INSPECTED

Morris Plains, NJ 07950 Cell Therapy Manufacturing Facility 

1HIS 

REPRESENT 

DOCUMENT LISTS OBSERVATIONS MADE BY THE FOA REPRESENTATIVE[S} DURING THE INSPECTION OF YOUR FACIUlY. THEY ARE INSPECTIONAL OBSERVATIONS, ANO DO NOT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, OR HAVE IMPLEMENTED, OR PLAN 10

OR 

IMPLEMENT, CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS 1HE OBJECTION DR ACTION WITH THE FDA REPRESENTATIVE(S) DURING THE INSPECTION SUBMIT THIS INFORMATION TO FDA AT THE ADDRESS ABOVE. IF YOU HAVE ANY QUESTIONS,PLEASE CONTACT FDA AT THE PHONE NUIABER AND ADDRESS ABOVE. 

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

a. An audit team is defined as including a "qualified auditor," however, there is no stipulation as to what qualification for

auditing would entail. · 

b. It is actual practice that the audit report would be reviewed by Quality Systems personnel but this is not stated in the

SOP. 

8. There is no documentation to support the fonnulas used in th · spreadsheets,

Results, and In Process and Final Product! Results, used to generate sample analysis results. 

9. There is no documentation that Senior Manufacturing Associate. has received cGMP training.

EMPLOYEE(S} NAME ANO mLE (Print or Type) 

Mary P. Padgett, CSO 

Gang Wang, Ph.D., Biologist 

Keith Wonnacott, Ph.D., Chief, Cel)ular

Therapy Branch 

Thomas P. Finn, Ph.D., Microbiologist 

Helen 8. Ricalde, CSO

DATE ISSUED

February ·1s, 2007

INSPECTIONAL OBSERVATIONS PAGE of 2PAGES 

/s/

SEE . 

REVERSE

OFTTl/5

PAGE 

EMPLOYEE(Sl SIGNATURE 

FORM FDA 483 (4/03) PREVIOUS EDITION OBSOLETE (,sc..,,.,.,,,,,v.,.,...,.,_ ,..,,EF)