FDA 483 - Pharmaceutics International, Inc. - July 10, 2020

Pharmaceutics International, Inc. in Cockeysville, MD, a pharmaceutical manufacturer, received five observations during an FDA inspection from July 6-10, 2020. The inspection revealed significant deficiencies in aseptic processing, including inadequate equipment design and maintenance, insufficient environmental controls, and a lack of established procedures to prevent microbiological contamination. These issues collectively compromise the sterility assurance of drug products manufactured at the facility.