FDA EIR - Haemonetics Manufacturing, Inc. - September 22, 2023

An FDA surveillance inspection of Haemonetics Manufacturing, Inc. in Covina, CA was conducted from September 18-22, 2023. This inspection, performed under Compliance Program 7356.002A for sterile drug process inspections, focused on the manufacturing of combination drug/device blood collection units, including the filling and sterilization of Anticoagulant Citrate Phosphate Double Dextrose (CP2D) Blood Bags with Additive Solution (AS3). While no FDA Form 483 (Inspectional Observations) was issued, the inspection identified two primary areas requiring attention. Firstly, the company did not consistently adhere to its established procedures for auditing a critical supplier of Adenine, an additive solution. Secondly, the firm's cleaning procedures for manufacturing areas, specifically regarding drain contact time and floor cleaning frequency/solution application, were not consistently followed as documented, and supporting scientific validation for these practices was lacking. Furthermore, documentation for on-the-job training of third-party cleaning personnel was deemed insufficient. Management acknowledged these observations during the closeout meeting and committed to implementing corrective actions. These actions will be subject to verification during the next FDA inspection.