Medalliance, LLC – FDA 483, Jun 18, 2026

MedAlliance, LLC, a manufacturer of sterile medical devices and drug formulations in Irvine, CA, was cited for significant deficiencies during an FDA inspection. Observations included inadequate documentation and maintenance of cleanliness and contamination control during sterile device assembly and packaging, specifically concerning a laminar flow hood. Additionally, the firm failed to implement proper production controls for product release, delivery, and post-delivery activities, including a lack of review and verification of production records by the QC unit.