FDA 483 - coast quality pharmacy, llc - May 09, 2019

During an inspection conducted from April 25 to May 9, 2019, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Coast Quality Pharmacy, LLC, operating as Anazao Health. The inspection, led by Investigator Jennifer L. Huntington, identified significant concerns regarding the company's production of sterile and non-sterile drugs. Key observations included a failure to adequately evaluate and address actionable microbial contamination (such as Bacillus subtilus, Bacillus cereus, and Penicillium decumbens) found in aseptic processing areas. This led to the distribution of numerous potentially compromised sterile drug products without proper impact assessment. The firm also repeatedly failed to use pharmaceutical-grade components for drug formulations, a concern previously noted in a 2018 inspection. Further violations involved inadequate validation of aseptic and sterilization processes, including media fills that did not represent maximum batch sizes and a lack of validation for critical processing machinery. The company's written stability program was found deficient, lacking comprehensive testing for chemical impurities, microorganisms, yeasts, molds, and endotoxins at appropriate intervals. Finally, the firm used non-sterile disinfecting agents in critical ISO 5 and ISO 7 clean rooms, compromising environmental control. These observations highlight deviations from current Good Manufacturing Practices (GMP). Anazao Health is required to investigate these issues thoroughly, implement comprehensive corrective actions, and ensure all processes and controls meet regulatory standards to safeguard product quality and patient safety.