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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Incomplete Response Memorandum - Spherusol


To:          File STN BL STN 125354/0

From:      Deborah Trout, Committee Member, CBER, OCBQ, DMPQ, HFM-675
Through:  Carolyn Renshaw, Branch Chief, MRB1, DMPQ, OCBQ, HFM-675
Subject:   Initial review of Allermed’s CR letter responses to determine acceptability for filing as a complete response.

I have completed an initial review of the CR letter responses and recommend that the responses should not be considered complete based on the missing information noted below.
Concerning response to item 35
You have not provided the requested information. Please note ----------(b)(4)----------------------------------------------------------. Please supply validation data to support the--------(b)(4)------- and hold time(s) for the -(b)(4)- bulk drug substance. If -(b)(4)-------------- data is unavailable please explain how ---------(b)(4)-------- was validated to ensure its capacity for excluding contamination for the longest hold period encountered during routine production.
Concerning response to item 36
Data provided did not address ----------(b)(4)--------. Please provide data demonstrating that you have achieved ------------------------------------(b)(4)-----------------------------------------.