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

Source: https://www.keypedia.com/records/483/prisma-health-outsourcing-facility/3f18033c-714b-43c5-96b5-a2185a08cedb

> FDA 483 for Prisma Health Outsourcing Facility on March 03, 2023. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Prisma Health Outsourcing Facility
- Inspection Date: 2023-03-03
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

## Related Officers

- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.keypedia.com/companies/prisma-health-outsourcing-facility/506a0d33-51c2-42b0-bb6a-50526ae23c91

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9