# FDA 483 - Alliance Medical Products, Inc. DBA Siegfried Company - May 21, 2021

Source: https://www.keypedia.com/records/483/alliance-medical-products-inc-dba-siegfried-company/21c748df-9209-4f85-987a-939fc1e76072

> FDA 483 for Alliance Medical Products, Inc. DBA Siegfried Company on May 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alliance Medical Products, Inc. DBA Siegfried Company
- Inspection Date: 2021-05-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Alliance Medical Products, Inc. DBA Siegfried Company in Irvine, CA, a sterile drug manufacturer, revealed significant deficiencies across four observations. The firm failed to maintain adequate records for equipment monitoring, including missing temperature data and numerous unaddressed alarms. Additionally, the quality control unit's procedures were not consistently followed or adequately documented, leading to issues with aseptic processing, investigations, and equipment maintenance. The firm also failed to thoroughly investigate out-of-specification bioburden results and endotoxin testing suitability failures, and environmental monitoring in aseptic areas was found to be deficient.

## Related Documents

- [EIR - 2013-07-10](https://www.keypedia.com/records/eir/alliance-medical-products-inc-dba-siegfried-company/7a1e9df1-04f8-4c6e-81a1-141a93d65b02)
- [EIR - 2013-08-16](https://www.keypedia.com/records/eir/alliance-medical-products-inc-dba-siegfried-company/e2dc6c16-4578-46a6-95d3-9a8bad157245)
- [483 - 2017-05-26](https://www.keypedia.com/records/483/alliance-medical-products-inc-dba-siegfried-company/83bbfc5d-f77f-4ccd-89ce-9c2db05e341a)
- [483 - 2025-11-07](https://www.keypedia.com/records/483/alliance-medical-products-inc-dba-siegfried-company/c9e0f9f1-3a0d-4415-af2b-48eba6d77484)

## Related Officers

- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)
- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.keypedia.com/companies/alliance-medical-products-inc-dba-siegfried-company/3daf2f25-e22a-41c0-bcd9-d0f8ef1ab602

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