FDA 483 - Unither Manufacturing LLC. - October 15, 2021

Unither Manufacturing LLC. in Rochester, NY, a contract human drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight a failure to thoroughly investigate discrepancies, inadequate maintenance and sanitization of equipment, and a lack of adherence to quality control procedures. Repeated issues with environmental control and a lack of proper documentation for component approval and cleaning records indicate systemic problems affecting the quality and safety of sterile human drug products.