Alliance Medical Products, Inc. DBA Siegfried Company – FDA EIR, May 26, 2017

An FDA inspection of Alliance Medical Products, Inc. in Irvine, CA, was conducted from April 24, 2017, to May 26, 2017. This comprehensive pre-approval and Good Manufacturing Practice (GMP) inspection focused on the company's role as a contract manufacturer of sterile human drugs. The inspection aimed to assess overall GMP compliance and review pending Abbreviated New Drug Applications (ANDAs). While previous deficiencies from a 2015 inspection regarding sterilization load validation and environmental monitoring data trending were reportedly corrected, the current inspection identified several significant issues. Key GMP violations included inadequate growth promotion testing for aseptic media fills, unrepresentative sampling of analyst gloves during sterility testing, and failures in following and documenting established test procedures. Facility-related issues involved deficient segregation areas for components and products, and employees lacking required training for visual inspection tasks, specifically one inspector not using prescribed corrective lenses, leading to unsegregated potentially rejected vials. The quality control unit's procedures were not fully followed, and there were significant delays in investigating environmental monitoring excursions. For the pre-approval inspection, observations noted analytical test methods were neither adequately transferred nor validated, Excel spreadsheets for calculating test results were not validated, and instrument out-of-specification results and stability chamber qualifications were not properly investigated or adequate. Alliance Medical Products, Inc. committed to providing a written response to the identified deficiencies within fifteen working days.