FDA 483 - Chartwell Pharmaceuticals LLC - September 26, 2018

This FDA Form 483 report details observations made during an inspection of Chartwell Pharmaceuticals, LLC in Congers, New York, a pharmaceutical drug manufacturer. The inspection revealed significant deficiencies across multiple areas, including a lack of written procedures for equipment cleaning validation, warehousing, and quality control unit responsibilities, as well as inadequate facility space leading to potential mix-ups and contamination. These issues indicate a general lack of adherence to good manufacturing practices.