FDA 483 - SC Johnson Professional USA, Inc. - October 30, 2018

The FDA inspected Deb USA Inc. in Stanley, NC, a drug manufacturer, from October 22-30, 2018, and issued nine observations. The inspection revealed significant deficiencies in quality control, laboratory practices, and equipment design, particularly concerning microbiological testing, data integrity, and water systems. Several issues were repeat observations from previous inspections, indicating systemic failures to ensure product quality and compliance with established procedures and regulations.