FDA 483 - Curia Global, Inc. - January 15, 2019

Albany Molecular Research Inc. in Albany, NY, a manufacturer and controlled testing lab, received a Form 483 with four observations. The inspection revealed deficiencies primarily related to inadequate cleaning procedures, failures in following quality control unit responsibilities, and issues with inventory/warehouse systems and batch production records. These observations indicate a lack of adherence to established procedures and potential risks to product quality and traceability.