Life South Community Blood Centers - Feb. 27, 2020
Issue Date
Feb 27, 2020
Region
Southeast
Category
Drug
$117.00
Contact Name
Kimberly Kinsell
Contact Title
General Counsel, Chief Privacy Officer/Chief Safety Officer
Address 1
4039 Newberry Rd.
City
Gainesville
State
FL
Zip/Postal Code
32607
Country
United States
Inspection Range
Feb 21, 2020 - Feb 27, 2020
Pages
4
First Observation
Investigations are incomplete for cord blood units that fail specifications during stability testing and
failed stability results are not reported as Biological Deviation Reports (BPDRs) to the Agency or
reported to the BLA.
Investigator(s): Jacqueline Diaz-Albertini