Professional Disposables International, Inc. – FDA 483, May 28, 2019

Professional Disposables International, Inc. in Orangeburg, NY, a drug and device manufacturer, was cited for multiple deficiencies during an FDA inspection. The observations highlight significant issues with data integrity, laboratory controls, quality unit oversight, and validation processes. Key concerns include inadequate computer system controls, uninvestigated out-of-specification results, and failures in managing non-conformances and supplier requirements.