FDA 483 - Prisma Health Outsourcing Facility - March 03, 2023

This FDA Form 483 details observations from an inspection, citing deficiencies in procedures to prevent microbiological contamination and aseptic processing area conditions.

**Microbiological Contamination Prevention:** * A plastic sleeve and laminated form used in ISO 5 LAFUs within the ISO 7 Filling Suite for operational status were not included in the firm's cleaning and disinfection schedule. * Compounding technicians wrote on paper batch records in the ISO 7 Filling Suite during aseptic processing of Ketamine 30mg/6mL, Lot (b)(4), on 2/24/2023. Paper was placed on an unprotected laptop keyboard. * A bottle of (b)(4) was hung on the ISO 5 LAFU bar during aseptic processing, and the firm failed to assess its impact on unidirectional airflow, despite being observed in smoke studies.

**Aseptic Processing Area Deficiencies:** * (b)(4) trash cans with hard-to-clean surfaces were used in the ISO 7 Gowning and ISO 7 Filling suites, potentially retaining particulates and microorganisms. * An unprotected laptop keyboard used for data entry in the ISO 7 Filling Suite had hard-to-clean areas. A technician failed to disinfect (b)(4) sterile gloves after data entry during Ketamine HCL Injection Solution 30 mg/6 mL (5mg/mL) Syringe, Lot (b)(4) production. The