FDA EIR - Alliance Medical Products, Inc. DBA Siegfried Company - August 16, 2013

**Establishment Inspection Report Summary: Alliance Medical Products, Inc.**

**Inspection Overview:** - **Company Name:** Alliance Medical Products, Inc. - **Location:** Irvine, CA - **FEI Number:** 2027189 - **Inspection Dates:** July 10, 2013, to August 16, 2013

**Regulatory Framework:** The inspection was conducted under several compliance programs, including Drug Manufacturing Inspections, Sterile Drug Process Inspections, Pre-Approval Inspections, and Inspection of Medical Device Manufacturers. The inspection was part of the LOS-DO FY’13 Work Plan.

**Main Violations/Issues:** The inspection revealed significant cGMP deficiencies and issues related to NDA processes. Key violations included: - Inadequate method transfer for test methods, lacking evaluations for linearity, accuracy, and specificity. - Test methods for determining related substances were not stability indicating. - Insufficient control mechanisms to prevent deletion of electronic raw data. - Lack of unique user access for administrative functions. - Inadequate laboratory practices, including non-archived logbooks and lack of sample reconciliation. - Inadequate process validation and monitoring for nonviable particulates. - Changes in test methods and sampling requirements without supporting data.

**Required Actions:** The firm received a 16-item FDA 483: Inspectional Observations, requiring corrective actions to address the identified deficiencies. These include ensuring proper method validation, improving data integrity controls, adhering to validated test methods, and ensuring comprehensive process validation and monitoring practices.

**Conclusion:** Alliance Medical Products, Inc. must address the outlined deficiencies to comply with FDA regulations and ensure the safety and efficacy of their drug and medical device manufacturing processes.