Day

November 12, 1999
12
Nov

Apheresis Technologies Trials Software & Part 11

November 12, 1999
Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75....
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