cGMP News & Analysis

Alvotech (ALVO) Receives FDA Form 483 from June 2026 Inspection

Alvotech (ALVO) completed a routine FDA surveillance inspection at its Reykjavik facility on May 11, 2026, with the FDA issuing a Form 483 on May 8, 2026. The company stated that the observations are manageable and do not indicate significant operational issues. Alvotech plans to resubmit its relevant BLAs in Q2 2026 and maintains its outlook for FDA approval within the 2026 calendar year. This situation reflects the firm's commitment to complying with regulatory standards and improving its manufacturing processes.