FDA 483 - Pharmaceutics International, Inc. - October 27, 2017

Pharmaceutics International, Inc. in Cockeysville, MD, a drug manufacturer, received a Form FDA-483 citing multiple significant deficiencies. These issues include inadequate equipment maintenance and qualification, a deficient environmental monitoring system for aseptic processing, and insufficient controls over computer systems and production records. The inspection also found problems with purified water system design, blend uniformity procedures, adherence to sterile product contamination prevention, and the thoroughness of discrepancy investigations.