FDA 483 - Central Admixture Pharmacy Services, Inc. - September 11, 2018

This FDA Form 483 details observations from an inspection concerning the aseptic processing of sterile drug products. The facility operates with multiple ISO Class 5 hoods within ISO Class 7 cleanrooms.

Several deficiencies were noted: 1. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination are not established. Specifically, inadequate aseptic technique was observed during the (b)(4) of vial contents and sealing of IV bags. Different techniques for (b)(4) contents from drug vials by multiple technicians in separate ISO Class 5 hoods were observed, with some blocking first air from HEPA filters. Additionally, an operator filling and sealing IV bags was observed frequently entering and exiting the ISO Class 5 workspace, which was not minimized. 2. **Facility Design and Aseptic Processing Areas:** Separate or defined areas to prevent contamination or mix-ups are deficient. The design of the ISO Class 7 (b)(4) Room, which houses (b)(4) ISO Class 5 hoods, lacks adequate spacing. Personnel movement was impeded, requiring technicians to re-position carts, potentially disrupting production in multiple hoods. 3. **Environmental Monitoring:** The system for monitoring environmental conditions in aseptic processing areas is deficient. Environmental monitoring of the (b)(4) ISO Class 5 hoods in the cleanrooms is not adequate to assure cleanroom operations are met during operations. 4. **Component Receipt Procedures:** Written procedures for the receipt of components, drug