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

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/d0e21071-d0ab-4ae3-96dc-82ef337c2040

> 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: Central Admixture Pharmacy Services, Inc. in Phoenix, AZ, an outsourcing facility, was inspected and cited for significant deficiencies across its production, laboratory, facilities, and quality systems. Key issues include inadequate aseptic process validation, poor maintenance of aseptic processing equipment, insufficient laboratory record-keeping for calculations, and a lack of control over computer systems for assay data. Additionally, the firm failed to thoroughly review unexplained discrepancies and maintain sterility testing equipment calibration.

## Related Documents

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## Related Officers

- [Christopher M. Jenner](https://www.keypedia.com/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)
- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

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