FDA 483 - AnazaoHealth Corporation - January 30, 2015

AnazaoHealth Corporation, an outsourcing facility located in Las Vegas, Nevada, received an FDA Form 483 following an inspection conducted from January 20-30, 2015. The inspection revealed significant deficiencies primarily concerning the facility's compliance with current Good Manufacturing Practices (cGMP) for sterile drug products and specific requirements for outsourcing facilities.Key observations included inadequate validation of sterilization processes, highlighted by inappropriate samples and lack of comprehensive testing for sterile pellet products. The company also failed to thoroughly investigate multiple sterility failures for Testosterone and Estradiol pellets, lacking robust root cause analysis. Laboratory controls were found deficient, specifically regarding the lack of validated expiration dates for sterile container components and absence of release testing procedures.Furthermore, the inspection identified the absence of a written stability testing program to support product Beyond Use Dates, particularly for sterility and endotoxin. Aseptic processing areas exhibited issues with inappropriate personnel gowning, including operators wearing street clothes under non-sterile attire and re-using inadequately sterilized goggles. General aseptic techniques were not consistently followed, leading to contamination risks. Facility deficiencies included difficult-to-clean surfaces with signs of corrosion in clean rooms. The environmental monitoring system was found lacking, with issues in media qualification, unvalidated incubation conditions, and insufficient personnel monitoring.The company was also cited for using bulk drug substances from manufacturers not registered with the FDA and for inadequate labeling on several drug products, missing required statements like "This is a compounded drug," "Not For Resale," compounding date, and adverse event reporting information. AnazaoHealth Corporation is required to address these observations with comprehensive corrective actions to ensure the quality, safety, and compliance of its compounded drug products.