FDA 483 - East Orange VA Medical Center - February 27, 2020

The FDA issued a Form 483 to VA New Jersey Health Care System in East Orange, NJ, following an inspection of their sterile drug product production. Seven observations were cited, highlighting significant deficiencies in aseptic processing, environmental controls, facility cleanliness, and the use of appropriate cleaning and disinfecting agents. These issues indicate a lack of adequate controls to prevent contamination during sterile drug manufacturing.