Record of Telephone Conversation, April 11, 2014 - RAGWITEK

Submission Type: BLA Submission ID: 125478/0 Office: OVRR

Product: Short Ragweed Pollen Allergen Extract
Applicant: Merck Sharp & Dohme Corp.
Telecon Date/Time: 11-Apr-2014 09:17 AM 
Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request
Author: DEBORAH TROUT
Telecon Summary: Request for additional information regarding cleaning validation results for removed of cleaning agent contact equipment.

FDA Participants: Deborah Trout
Non-FDA Participants: Scott Greenfeder, Ph.D.

Telecon Body:
Deborah Trout e-mailed Dr. Scott Greenfeder to request that Merck provide cleaning validation results for the removal of cleaning agent on MK-3641 product contact equipment -------------(b)(4)------------------------------, and line assembly) at Catalent Pharma. Deborah stated that the BLA presents product removal results only.
