Radia Industry Co. 6/3/97 Sterilization of plasma separators

1. Failure to conduct processing control operations in a manner designed to assure that the device conforms to applicable specifications, as required by 21 CFR 820.100(b)(2). For example, there was also an incorrect maximum conveyor speed observed on February 24, 1997, by the investigator and one member of the firm. An operator is required to manually change the upper and lower limits of the speed to insure that the correct absorbed dose is delivered. The computer software is supposedly designed to prompt the operator when a change in conveyor speed is necessary.