FDA 483 - Morton Drug Company dba Morton LTC - August 31, 2018

Morton Drug Company dba Morton LTC in Neenah, WI, was inspected from August 27-31, 2018, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in aseptic processing, including inadequate cleaning procedures for beta-lactam drugs, insufficient disinfection of materials entering aseptic areas, and media fills that did not accurately simulate production operations. These issues indicate potential risks of product contamination and compromise of sterility.