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Information Request Letter, May 23, 2012 - SOLX® System




 
DEPARTMENT OF HEALTH & HUMAN SERVICES                                            
         Public Health Service
 


                                                                                 
                                           Food and Drug Administration

1401 Rockville Pike

Rockville, MD 20852-1448

 

Our Reference:  BN110059/0

 

Hemerus Medical, LLC

Attention: Ms. Lynn Jensen

May 23, 2012

Sent by email: ljensen@hemerus.com

 

Dear Ms. Jensen:

 

We are reviewing your October 28, 2011 new drug application (NDA) for HEMERUS 
LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with 
CPD Anticoagulant and SOLX® Additive.  We have determined that the following 
information is necessary to continue our review:

 

Sterilization:

 

1.     Please clarify if the complete system is autoclaved and if the system is 
over-pouched/packaged when sterilized.

 

2.     Please provide how many systems are in each tray and trolley.  Please 
clarify how many systems are in a full load.

 

3.     Please explain if each tray is configured in the same way and do they 
have the same number of systems.

 

4.     Please provide a picture/diagram of how the system is configured in a 
trolley.

 

5.     Please explain how the system is coiled and packed for sterilization and 
if this is clearly defined in an SOP.

 

6.     Please provide a picture of the configuration of the system for 
sterilization (including how the tubing is configured along with the bags and 
filter).

 

7.     Please clarify if the systems are visually inspected for kinked tubes 
after sterilization during routine operations.

 

8.     With this method of sterilization, ---(b)(4)-- is a critical parameter. 
 Please explain how you ensure during routine production the (b)(4) is operating 
as it should.

 

9.     You stated that your sensors are calibrated every ---(b)(4)-- and that 
the sensors were calibrated before the validation.  Please clarify if the 
sensors were still within calibration after the validation and revalidation was 
completed.

 

10. Please provide the raw data of each run for the validation and revalidation.

 

11. Please indicate what organisms are being found on your product and in your 
facility.

 

12. Please provide the population and resistance of the bioburden on your 
product and at your facility.

 

13. Please provide the population and resistance of the BIs.

 

14. Are you performing periodic resistance testing?

 

15. In the validation and revalidation the minimum F0 values were 
------(b)(4)----- minutes, respectively.  Please clarify if there were any BIs 
in those systems.

 

16. In Study LAB/VR/039/06, several thermal sensors did not reach (b)(4) when 
sterilization dwell time started.  Those locations could be indicative of a cold 
spot.  Locations ---(b)(4)---- did not have BIs at those locations.  Please 
address this concern.

 

17. The BIs used in LAB/VR/039/06 did not have a D-value for (b)(4) 
sterilization on the COA. Please explain how resistance can be evaluated.

 

18. Please clarify if you had any sterility failures of the final product.  If 
so provide a summary report of the investigation, root cause, and corrective and 
preventative action associated with these failures.

 

19. Please provide the firm’s sterility release criteria.  Will you be using 
parametric release?

 

20. During your validations, please clarify if there are any other changes 
(besides using the           ---(b)(4)---) from the actual system that is being 
validated.  For example, are all the other bags, connections, tubes, and etc. 
the same (material, dimensions, etc.). 

 

21. The new bag arrangement is considered a new load configuration.  Additional 
runs need to be performed at the new load configuration for the Agency to be 
able to evaluate the effectiveness of your sterilization cycle.

 

22. In your validation, your cold spots have become hot spots and locations that 
you have not identified as cold spots are lagging behind the cold spots you have 
identify.  Please explain and provide data on how you selected your cold spots.

 

23. In the sterilization validations you provided the (b)(4) test method.  In 
the diagrams you indicate that the bags are cut off.  Please clarify if all bags 
are cut off and tested individually or pooled together.  How have you ensured 
all fluid pathways have been assessed for (b)(4)

24. You have also provided the product sterility test method. Please clarify how 
you ensured all fluid pathways have been assessed for sterility. Please also 
clarify if each bag is tested individually or if the complete system is tested.

 

----(b)(4)----------:

 

25. -----------(b)(4)--------------------------------------.

 

26. 
-----------(b)(4)------------------------------------------------------------.

 

27. 
-----------(b)(4)----------------------------------------------------------------.

 

28. 
-----------(b)(4)--------------------------------------------------------------------------------------------------------.

 

29. -----------(b)(4)--------------------------------------------------------.

 

The review of this submission is on-going and issues may be added, expanded 
upon, or modified as we continue to review this submission. 

 

Please submit your response to this information request as an amendment to this 
file by June 6, 2012 referencing the date of this request.  If you anticipate 
you will not be able to respond by this date, please contact the Agency 
immediately so a new response date can be identified.

 

The action due date for this file is August 31, 2012.

 

If you have any questions, please contact me at (240) 507-8446.

 

Sincerely,

 

 

 

Sonday L. Kelly, M.S.

Regulatory Project Manager

FDA/CBER/OBRR
 

    
 
