FDA EIR - Avista Pharma Solutions, Inc. dba Cambrex - November 09, 2018

Avista Pharma Solutions in Longmont, CO, underwent an initial FDA current Good Manufacturing Practice (CGMP) inspection from November 7-9, 2018, focusing on its control testing laboratory for human and animal drugs. The main violation identified was the Quality Unit's failure to review and approve all associated records related to the testing of Active Pharmaceutical Ingredient (API) drug products. Specifically, computerized software audit trails for GMP testing of treprostinil diolamine API and riluzole API were not being reviewed by Quality Assurance or its designee. The company's corporate procedure for technical review of laboratory data also lacked provisions for computerized audit trail review, which are crucial for ensuring data integrity by documenting data creation, modification, and deletion. This observation cited a deficiency in adhering to 21 CFR 211.22(a), related to Quality Control Unit responsibilities. In response, management committed to providing a written reply to the FDA within 15 business days. They also committed to revising procedures to include audit trail reviews and had already conducted a retrospective review of the affected audit trails. The company is actively pursuing a Data Integrity Remediation Project Plan to address audit trail capabilities and implement necessary corrective actions across all relevant computerized systems.