FDA 483 - Atlas Pharmaceuticals, LLC - September 26, 2017

Atlas Pharmaceuticals, LLC, an outsourcing facility in Phoenix, AZ, was cited with 11 observations for significant deficiencies in its manufacturing processes for sterile drug products. The findings indicate a systemic lack of control over microbiological contamination, environmental monitoring, sanitation, personnel training, and quality control, posing serious risks to product sterility and patient safety. Key issues include media fill failures, inadequate sterilization validations, poor environmental monitoring, and improper material handling.