FDA 483 - AnazaoHealth Corporation - July 29, 2022

AnazaoHealth Corporation, an outsourcing facility in Las Vegas, NV, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. Observations included a lack of quality unit authority over production records and investigations, absence of written production procedures, inadequate batch failure investigations linked to serious adverse events, and unvalidated sterility test methods. Additionally, aseptic processing areas were found to have deficient cleaning and disinfection systems due to improper equipment storage.