Chartwell Pharmaceuticals Carmel LLC – FDA 483, Jan 11, 2024

Chartwell Pharmaceuticals Carmel LLC, a drug manufacturer in Carmel, NY, received a Form 483 with three observations following an FDA inspection. The inspection revealed significant issues including the use of unqualified and uninstalled equipment, inadequate computer system controls leading to data integrity concerns, and a failure to record and justify deviations from approved production and process control procedures. These findings indicate a lack of adherence to cGMP requirements for drug manufacturing.