FDA 483 - Curia Massachusetts, Inc. - May 24, 2017

Albany Molecular Research Inc. in Burlington, MA, received a Form 483 with two observations during an FDA inspection. The firm was cited for failing to follow procedures to prevent microbiological contamination during aseptic filling of sterile drug products. Additionally, the quality control unit did not fully adhere to its responsibilities and procedures, specifically by using unofficial documents for cGMP activities.