FDA 483 - Sklar BOV Solutions, Inc. - May 23, 2025

Sklar BOV Solutions, Inc. in Statesville, NC, a drug manufacturer, was inspected and received seven observations related to significant deficiencies in their quality system. The inspection revealed failures in equipment cleaning validation, water system controls, process validation, raw material identity testing, equipment qualification, adherence to written procedures, and annual product reviews. These issues indicate a lack of robust controls to ensure drug product quality and consistency.