MedAlliance, LLC – FDA 483, Jun 18, 2026
MedAlliance, LLC, a manufacturer of sterile medical devices in Irvine, CA, received a Form 483 for significant deficiencies in contamination control during assembly and packaging processes. Inspectors observed issues with a laminar flow hood, including smudges, lack of cleaning procedures, and obstructed airflow. Additionally, the firm failed to implement adequate production controls, specifically regarding the review and verification of production records prior to product release and distribution.
ID · 37da6f27-c544-4865-b71a-3346c08bc7c1
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