FDA 483 - Central Admixture Pharmacy Services, Inc. - May 24, 2021

Central Admixture Pharmacy Services Inc. in Harahan, LA, a producer of sterile drugs, received a Form 483 with four observations during an inspection from May 3-24, 2021. The observations highlight significant deficiencies in microbial contamination control, inadequate disinfection practices, and poor aseptic technique by personnel. Additionally, the facility had difficult-to-clean surfaces in critical aseptic processing areas, indicating potential risks to product sterility and quality.