From: Tull, Lori
Sent: Thursday, April 18, 2013 11:09 AM
To: 'Donna Regan'
Cc: Karandish, Safa; McCright, Brenton
Subject: CMC request for information
I am forwarding the following request for information. Please submit as soon as possible.
1. Please submit the following forms/documents that are shipped with each licensed unit to the transplant center (SOP SE.02.09):
- Notification of Cord Blood Shipment- SE.02B.XX with intended recipient name and unique identifier
- NMDP Shipment packet: product tag, product insert, final DE declaration, IDM report for HPC, Cord Blood, NMDP receipt of CBU form
- Receipt instructions
- Unit Receipt form
- Copy of unit confirmatory testing results
- SLCBB Customer Service Brochure
- Cord Blood Thaw Record SE.02L.XX
2. The Comprehensive Matched Unit Report that was received on 3/7/13 was prior to the implementation of ISBT 128. Please clarify whether or not there has been any changes to the report and if yes, please submit the latest version.
3. Please describe how the ISBT 128 final label (SOP SE.02.09) is attached to the cryopreserved CBU at the time of shipment.
4. Please submit the final version of Unit Detail Report (refer to the 3/12/12 email from Safa Karandish)
Lori A. Tull
Regulatory Management Staff
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
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