FDA 483 - Pharmaceutics International, Inc. - October 30, 2020

Pharmaceutics International, Inc. in Cockeysville, MD, a sterile drug manufacturer, was inspected from October 19-30, 2020. The inspection revealed significant deficiencies in aseptic processing procedures, including unsuitable environmental monitoring equipment and unreviewed particle excursions. The firm also failed to establish time limits for critical production phases and exhibited multiple failures within its Quality Control Unit, such as overdue CAPAs, undocumented equipment failures, and inadequate temperature monitoring.