Vaccines, Blood & Biologics

FDA Teleconference Email, August 2, 2012 - EVARREST

Tilghman, Tracy


From:             Tilghman, Tracy

Sent:              Thursday, August 02, 2012 8:07 AM

To:                 Ananyeva, Natalya

Subject:         FW: BLA 125392 FDA Teleconference 02Aug2012 8:00-10:00am

Attachments: b(4) data b(4).DOCX; b(4) data b(4) PDF; b(4) data FPPF.DOC; b(4) data FPPF.PDF











From: Chung, Jessica [ETHUS] ---b(4)------------------------------

Sent: Wednesday, August 01, 2012 8:56 PM

To: Tilghman, Tracy

Cc: Sillivan, Destry; Melhem, Randa

Subject: RE: BLA 125392 FDA Teleconference 02Aug2012 8:00-10:00am


Dear Tracy,

As requested, please find attached the b(4)  test results prior to the CV for b(4)  and FPPF (word and pdf format). Thanks,





From: Tilghman, Tracy []

Sent: Tuesday, July 31, 2012 10:07 AM

To: Chung, Jessica [ETHUS]

Cc: Sillivan, Destry; Melhem, Randa

Subject: RE: BLA 125392 FDA Teleconference 02Aug2012 8:00-10:00am


Ms. Chung,


Please be prepared to discuss the following issues/areas below:


1. Groupings and the validation plan for each group. In certain instances you employ a b(4) validation approach, and in others you only perform validation on b(4) of a group, and claim that the equipment is equivalent or identical.


· For CLN22 - Cleaning Validation should be performed on –b(4)-----. You should supply the results from at least –b(4)--- on the other

-b(4)- as soon as possible.

· CLN45 - Please consider using a b(4) strategy.  Not performing at least –b(4)- on each b(4) is generally not acceptable. Please also consider that the b(4) are not identical considering some






may have deteriorated more than others over time.

· VAL-R-0182 - Please consider using a b(4) strategy.  The –b(4)---------------------------------------------------------; it is not clear how can you equate them considering the deviations you encountered in other areas of CV due to deteriorating parts.


1a. Undergoing maintenance work is not an acceptable justification for not doing cleaning validation on a piece of equipment. If the maintenance work would significantly alter the equipment, re-validation/verification should be performed after the maintenance work to ensure that after maintenance the equipment is able to be cleaned using established cleaning cycles.


2.  Please be prepared to justify your acceptance limits for –b(4)--------------------. Please provide, prior to the teleconference, your actual b(4) test results that you check prior to CV, for comparative purposes.


2a. You have not adequately justified your acceptance limit for product –b(4)----------------

Additionally, you did not specify in your response regarding the b(4) samples, whether the ------b(4)-----------------------------------------------------------------------------------------

Please be prepared to provide further justification of your –b(4)------------- limit, and

clarification as to which –b(4)-------- was used to –b(4)------ the b(4) samples.


3. ---b(4)--------------------------------------------------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


4. Several cleaning validation runs of different pieces of equipment in various groups failed due to

issues with soft parts, piping - please explain why these have been overlooked and the plans in place to prevent recurrence.


5. Please justify how you would determine if an individual piece of equipment had somehow become degraded to an extent that the established and validated cleaning procedures were no longer effective when you only revalidate every –b(4)-- for a representative piece of equipment within your established equipment groups.


6. You stated that the ----b(4)--- -------------------------------------------------------------------------------------------------- have not been validated for each equipment at FPPF. Please clarify and address your comment in the initial response "validate longer time prior to commercial launch." Your response is not clear whether per your procedures a –b(4)------------------------ studies were not required to be completed " or you are planning to perform these studies, and they are not completed yet.


7.  CLN23 - please explain the issue and justify why it took 8 months to fix.


8.  For CLN 24, please specify the storage conditions for the "clean and dry –b(4)---- containers used to store b(4).  How do you assure that these containers are not contaminated prior to use?


9. CLN39 - please further clarify why the b(4) time was extended from ----b(4)---------------------, and what is the current –b(4)--time in practice.


10. Please justify your frequency of using –b(4)------, and do you have plans to monitor and adjust considering you still have a high percentage of contamination due to –b(4)-------------- in FPPF.



















From: Chung, Jessica [ETHUS] ---b(4)-----------------]

Sent: Thursday, July 26, 2012 4:27 PM

To: Tilghman, Tracy

Cc: Sillivan, Destry; Melhem, Randa

Subject: BLA 125392 FDA Teleconference 02Aug2012 8:00-10:00am


Dear Tracy/Destry/Randa,

Please find below the information for the teleconference on Thursday, 02Aug2012 8:00‐10:00am. Conference Dial In Numbers: US Toll Free: ---b(4)----------------------------------); Participant Conf. Code:



Ethicon/Omrix Attendees: Jessica Chung

Raina Dauria       –b(4)----   Samson Tom








As I understand, a list of questions and also a list of items that have been addressed and completed satisfactorily will be provided by FDA prior to the call so that we can prepare for an effective discussion. If you could please send them to me as soon as it becomes available, I will ensure the attendees have it.

Thank you. Kind Regards,



Jessica Chung

Regulatory Affairs

Ethicon Inc., a Johnson & Johnson Company

P.O. Box 151, Route 22 West

Somerville, NJ 08876-0151

Work: 1 908 541 3828







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

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