FDA 483 - Octapharma Plasma, Inc.

An FDA inspection of Octapharma Plasma, Inc. in Mesa, Arizona, a plasmapheresis facility, revealed significant deficiencies in record-keeping practices and adherence to standard operating procedures. The firm failed to maintain complete validation records and consistently follow procedures for medical incident reporting and donor communication logs. Furthermore, the inspection found that the firm did not always make reasonable attempts to notify donors of positive infectious disease test results, specifically regarding HIV.