FDA 483 - Alvotech HF - May 08, 2026

Alvotech HF, a biological drug manufacturer located in Reykjavik, Iceland, was issued an FDA Form 483 following an inspection conducted from April 29 to May 8, 2026. The inspection revealed five primary areas of concern regarding the facility"s adherence to quality standards. A significant violation involved the company"s handling of consumer complaints; since 2024, the site received 845 complaints related to product malfunctions but failed to identify root causes, follow up on available physical samples, or thoroughly investigate incidents reported by third-party contractors. Additionally, the FDA found that aseptic processing validations were inadequate, as airflow studies showed potential contamination risks during the vial-stopping process. The company also failed to properly investigate bacterial contamination found in its water systems, neglecting to extend risk assessments to the drug batches produced during those periods. Other issues included insufficient training requalification for staff performing visual inspections and the Quality Unit"s failure to generate mandatory environmental monitoring trend reports. Although these observations do not represent a final determination of non-compliance, Alvotech HF is required to respond to the FDA with a detailed plan for corrective actions to address these deficiencies and ensure the continued safety and purity of its biological products.