# FDA 483 - Alliance Medical Products, Inc. DBA Siegfried Company - May 26, 2017

Source: https://www.globalkeysolutions.net/records/483/alliance-medical-products-inc-dba-siegfried-company/83bbfc5d-f77f-4ccd-89ce-9c2db05e341a

> FDA 483 for Alliance Medical Products, Inc. DBA Siegfried Company on May 26, 2017. 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: 2017-05-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Alliance Medical Products, Inc. in Irvine, CA, revealed significant deficiencies in their manufacturing operations. The firm failed to adequately validate analytical test methods and computer spreadsheets, properly investigate out-of-specification results, and maintain appropriate environmental controls for stability chambers. Additional issues included inadequate laboratory sampling plans, non-adherence to established procedures, poor material storage, insufficient employee training, and failures in their corrective and preventive action system.

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

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