FDA 483 - Marcus Research Laboratory, Inc. - July 12, 2024

An FDA inspection of Marcus Research Laboratory, Inc. in St. Louis, MO, revealed significant deficiencies in equipment construction, design, and cleaning validation for their Povidone-Iodine drug substance manufacturing. Inspectors noted that stainless steel equipment surfaces appeared reactive with the iodine API, potentially forming toxic metal iodides. The firm also lacked adequate procedures for equipment design and cleaning validation, failing to properly assess impurity risks and validate cleaning methods for non-uniform surfaces.