FDA 483 - Solventum US LLC - September 06, 2024

During an inspection conducted from September 3-6, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Solventum US LLC's manufacturing facility in Columbia, MO. The inspection revealed two significant observations indicating potential deviations from regulatory expectations, particularly concerning Good Manufacturing Practices. The first observation detailed deficiencies in the company’s written stability program for drug products, including Soluprep-S, Duraprep, and Skin and Nasal Antiseptic. The methods used to evaluate degradation impurities for these products were not demonstrated to be stability-indicating, as mass balance analysis—essential for detecting all degradation products—had not been performed. This raises concerns about the assurance of drug product quality and shelf-life. The second observation highlighted inadequate controls over computer systems used in manufacturing. Specifically, electronic systems controlling equipment for filling and assembly operations lacked individual user login accounts, compromising data integrity and accountability. FDA investigators observed multiple personnel sharing a single login on critical production machinery. These observations, issued under the authority of the Federal Food, Drug, and Cosmetic Act, require Solventum US LLC to implement comprehensive corrective and preventive actions to ensure robust product stability testing and secure, auditable computer system access, safeguarding product quality and regulatory compliance.