FDA 483 - Noble Pharma, LLC - March 06, 2025

Noble Pharma LLC, a drug manufacturer in Menomonie, WI, was cited with three observations during an FDA inspection. The firm failed to adequately validate equipment and processes for drug manufacturing, lacked proper facility configuration to prevent contamination, and had deficient controls over computer systems, including the use of a default log-on. These issues indicate significant concerns regarding GMP compliance and data integrity.