FDA 483 - Central Admixture Pharmacy Services, Inc. - February 25, 2022

This FDA Form 483 was issued to Central Admixture Pharmacy Services, Inc., an outsourcing facility located at 2200 S 43rd Ave, Phoenix, AZ, following an inspection from February 14-25, 2022. The inspection revealed several deficiencies across production, laboratory, facilities/equipment, and quality systems.

**Production System:** * **Observation 1:** Procedures to prevent microbiological contamination of sterile drug products lacked adequate aseptic process validation. Specifically, a large red container used dynamically in the ISO 5 hood during Rocuronium production (Lot RN I) was not included in the 05/22/21 smoke study. Additionally, smoke studies failed to demonstrate laminar airflow, showing turbulent airflow around equipment/materials under static and dynamic conditions, and did not cover all sterile syringe operations. * **Observation 2:** Aseptic processing areas had deficiencies in maintaining equipment controlling aseptic conditions. Scratches were observed on the back wall of ISO 5 hoods during production of del Nido Formula (Lot RN I) and Rocuronium (Lot J.IIIN I) on 02/16/22 and 02/18/22, indicating non-smooth, difficult-to-clean surfaces.

**Laboratory System:** * **Observation 3:** Laboratory records lacked complete calculations for retesting amino acids. The written procedure "Amino Acid Analysis