
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

Non-FDA Participants:

Octapharma Stockholm:

Christina Leo

Katrin Karlson

 

Octapharma Vienna:

Andrea Buchacher

Stephanie Schertler

Gerald Elmecker

Joseph Trenkwalder

Simone Meindl

Barbara Rangetiner

 

Octapharma USA:

Stan Ammons

 

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

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.

END.

 

Reviewed by Jie He/ October 23, 2012