FDA 483 - Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy - September 27, 2019

The FDA conducted an inspection of Snyder Mark Drugs Roselle, Inc., operating as Mark Drugs Pharmacy, from September 16 to September 27, 2019. This inspection identified significant deficiencies in the firm's production of sterile and non-sterile drug products, indicating a lack of adherence to current Good Manufacturing Practices. Key observations included the failure to certify ISO 5 aseptic processing areas under dynamic conditions, specifically lacking smoke studies to demonstrate unidirectional airflow during simulated production. Investigators also noted the use of non-sterile wipes within these critical ISO 5 aseptic processing environments. Furthermore, the firm's media fill simulations, designed to evaluate aseptic processes, did not adequately represent worst-case conditions, maximum activities, or the full complement of personnel involved in operations, thus failing to sufficiently challenge aseptic procedures. Most critically, the inspection revealed a complete absence of endotoxin testing for intrathecal drug products and their non-sterile starting materials, providing no assurance of safety regarding endotoxin levels in these high-risk preparations. These observations highlight fundamental control issues that could compromise drug sterility and patient safety. Mark Drugs Pharmacy is required to promptly address these concerns, implementing comprehensive corrective actions to ensure compliance with regulatory standards and safeguard public health.