# FDA 483 - Central Admixture Pharmacy Services, Inc. - August 25, 2023

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/4e48f2ea-d68f-497e-980a-f92d6b66f712

> FDA 483 for Central Admixture Pharmacy Services, Inc. on August 25, 2023. 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: 2023-08-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Central Admixture Pharmacy Services Inc received a Form 483 detailing significant deficiencies in its quality control unit, aseptic processing, and laboratory controls. The observations highlight failures to ensure drug product sterility, purity, and strength, including inadequate investigations into particulate matter, microbial contamination, and adverse drug events. The firm also exhibited poor documentation practices, insufficient environmental monitoring, and facility maintenance issues, indicating a systemic lack of adherence to cGMP regulations for sterile drug production.

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## Related Officers

- [Dorit B Singh](https://www.keypedia.com/people/dorit-b-singh/281c84dd-149a-4d94-957f-03f5870f36ce)
- [Rachel C. Stanton](https://www.keypedia.com/people/rachel-c-stanton/36495725-366c-4138-a4d8-df3ce38fa9cd)
- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)
- [Xiaohui Shen](https://www.keypedia.com/people/xiaohui-shen/fc1a2812-b1e2-4580-999c-d4a99558a9b2)

Company: https://www.keypedia.com/companies/central-admixture-pharmacy-services-inc/714af0dc-626a-4ec1-b5b7-0c57ae7fee7a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6