FDA 483 - Walter's Pharmacy, Inc. - March 01, 2016

During an FDA inspection conducted from February 9 to March 1, 2016, Walter's Pharmacy, a producer of sterile drugs in Allentown, PA, received a Form FDA 483 listing significant observations related to their sterile drug manufacturing practices. The inspection highlighted critical deficiencies in ensuring the sterility of ophthalmic and oral inhalation solutions. Key issues identified included a severe lack of environmental control, with all sterile drug manipulations performed in a non-sterile, uncontrolled environment adjacent to a sink. Personnel protective apparel was critically inadequate; employees did not wear sterile garb such as gowns or sterile gloves during production, increasing contamination risks. The firm also lacked a written stability testing program, leading to incorrect beyond-use dates (BUDs) for sterile products that differed from established references. Furthermore, product formulations often varied from their reference standards. Additionally, there were no written procedures for sterile drug production, and component testing was insufficient to verify the identity of each ingredient. These observations indicate substantial deviations from manufacturing quality standards, necessitating comprehensive corrective actions to ensure product sterility, quality, and patient safety.