FDA 483 - Baxter Pharmaceutical Solutions, LLC - November 10, 2021

During an inspection conducted from November 2-10, 2021, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Baxter Pharmaceuticals Solutions, LLC, a contract manufacturing organization in Bloomington, IN. This document outlines significant observations indicating potential deviations from Good Manufacturing Practices.

The inspection identified three primary concerns. Firstly, the company failed to thoroughly review unexplained discrepancies, specifically regarding product defect trending. It was observed that the sample inspection criteria for rejected syringe units lacked scientific rationale, and high false reject rates often went without further investigation to determine true defect rates. Secondly, the facility demonstrated a persistent issue with insect ingress into classified manufacturing areas, including rooms where sterile products are filled and packaged. Despite several corrective and preventative actions (CAPAs) since 2018, recurring pest control events continued, indicating ineffective controls. Finally, the Quality Control unit was found to lack adequate authority to fully investigate errors. Specifically, quality personnel did not have immediate access or camera views into critical vial filling rooms, hindering their ability to observe operations and investigate issues effectively.

These observations highlight areas where Baxter Pharmaceuticals Solutions must implement robust corrective actions to ensure product quality, facility integrity, and compliance with regulatory standards.