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Record of Telephone Conversation, October 22, 2012 - Octaplas
Submission Type: BLA Submission ID: 125416/0 Office: OBRR
Product: Pooled Plasma (Human), Solvent/Detergent Treated
Applicant: Octapharma Pharmazeutika Produktionsges.m.b.H.
Telecon Date/Time: 22-Oct-2012 10:00 AM Initiated by FDA? Yes
Telephone Number: -------(b)(4)---------------
Communication Categorie(s): Information Request
Author: PRATIBHA RANA (Transcript received from Jie He)
Telecon Summary: Information Requests and clarifications
FDA Participants: Jie He, Destry Sillivan, Randa Melhem, Pratibha Rana
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
DMPQ and Octapharma first discussed CCIT study reports submitted in the BLA.
DMPQ asked Octapharma regarding sampling method used for OAB CCIT test. The firm stated that the CCIT was done with ----(b)(4)--------. DMPQ stated that only summary reports were submitted in the BLA, and asked Octapharma to provide a complete CCIT study protocol. Octapharma agreed to submit the complete study protocol.
DMPQ questioned Octapharma’s CCIT study on the test sensitivity and detection limit, particularly regarding --------(b)(4)------------------------ was used for the ---(b)(4)----------(b)(4)------ study. DMPQ further asked if the firm has conducted or considered to conduct a ---(b)(4)------- study to determine the test limit. Octapharma responded that ----(b)(4)--------------------------------------------------- was used in the study, and no ---(b)(4)--- study was conducted.
For the final visual inspection for CCIT, DMPQ asked Octapharma if there is any standard mechanical method, such as roller or pressure plate tests is used. Octapharma stated that no roller or plate pressure test is used in the final container visual inspection, and they will have internal discussion about this issue and will respond to the agency soon.
DMPQ and Octapharma then discussed the firm’s responses to the 483 observations during pre-license inspections at OAB and OPG.
Octapharma was asked if all the agreed upon study reports and SOP updates have been completed since no update report has been received. DMPQ stressed that these issues must be resolved satisfactorily before the BLA can be approved. Octapharma stated that they have not submitted any of the report to the agency, and agreed to look into this issue and will provide update soon.
Reviewed by Jie He/ October 23, 2012