FDA 483 - LGM Pharma Solutions, LLC - May 18, 2026

LGM Pharma Solutions, LLC, a drug product and API manufacturer in Irvine, CA, received an FDA Form 483 citing significant deficiencies in its quality systems. Observations included inadequate production controls for managing product variability, deficient laboratory controls with outdated method validation, failure to thoroughly investigate recurring out-of-specification results, and non-compliance with annual reserve sample examination requirements. These findings indicate a need for comprehensive improvements in the firm's adherence to current Good Manufacturing Practices.