FDA 483 - Customcoatial Compounding, LLC - March 08, 2019

Customceutical Compounding, LLC in Phoenix, AZ, was inspected regarding its production of sterile and non-sterile drugs. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, personnel gowning, and cleaning procedures for sterile products. Additionally, the firm failed to prevent cross-contamination during the production of hazardous non-sterile drug products.