FDA 483 - STAQ Pharma, Inc. - September 03, 2020

During an inspection from August 25 to September 3, 2020, the U.S. Food and Drug Administration issued an FDA Form 483 to STAQ Pharma, Inc., an outsourcing facility in Denver, Colorado. The inspection revealed significant observations regarding the company's manufacturing practices for sterile drug products. Key violations included inadequate investigations into product discrepancies, such as leaking syringes and the presence of foreign particles in multiple sterile drug product lots like Ketamine HCL and Hydromorphone HCL, without fully determining root causes. Procedures designed to prevent microbiological contamination were found deficient, lacking adequate validation of aseptic processes, evidenced by turbulent airflow in critical production areas and non-aseptic material transfer. Furthermore, environmental monitoring systems in aseptic processing areas were insufficient, with media plates not containing necessary neutralizing agents and a lack of viable and particle monitoring during aseptic setups. Cleaning and disinfection protocols for aseptic areas were also found to be deficient, failing to ensure proper contact times and appropriate use of cleaning materials. Lastly, labels for several drug products, including Fentanyl Citrate and Morphine Sulfate, were incomplete, missing essential information such as the dosage form. These observations highlight concerns with STAQ Pharma's adherence to regulatory requirements for compounding sterile drugs. The company is required to formally respond to the FDA, outlining comprehensive corrective actions to address each observation and ensure patient safety and product quality.