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

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/5f2a5870-f52d-483a-a3a8-046fe4e840ff

> FDA 483 for Central Admixture Pharmacy Services, Inc. on February 25, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Central Admixture Pharmacy Services, Inc.
- Inspection Date: 2022-02-25
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: 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

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## Related Officers

- [Christopher M. Jenner](https://www.keypedia.com/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)
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Company: https://www.keypedia.com/companies/central-admixture-pharmacy-services-inc/b0cd49a7-1942-45bd-9755-fe480400a1b2

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face