LGM Pharma Solutions, LLC – FDA 483, Mar 1, 2024

LGM Pharma Solutions, LLC in Irvine, CA, received a Form FDA 483 with four observations following an inspection from February 21 to March 1, 2024. The inspection revealed significant deficiencies in the firm's quality control unit procedures, production and process controls, laboratory data integrity, and equipment cleaning and maintenance. These issues indicate a lack of adequate controls to ensure drug product quality and purity.