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

Marcus Research Laboratory, Inc. received an FDA Form 483 following an inspection conducted from July 8 to July 12, 2024. The inspection revealed several significant observations pertaining to the company's manufacturing processes and quality systems, particularly concerning equipment suitability and cleaning validation for drug substance production. A key concern, noted as a repeat observation, involved equipment product contact surfaces. The FDA observed that stainless steel surfaces of manufacturing equipment, including mixers, appeared reactive with Iodine, a component of their Povidone-Iodine drug substance. This reactivity could potentially produce toxic metal iodides, altering product quality beyond established specifications. Furthermore, the inspection highlighted that manufacturing equipment surfaces were non-uniform, indicating either degradation over time or initial construction unsuitable for pharmaceutical use and effective cleaning. Another repeat observation focused on inadequate cleaning validation procedures. The firm's risk assessment for impurities did not adequately consider potential contaminants generated from the reaction between Iodine API and metal equipment. Additionally, cleaning validation for non-uniform surfaces relied on an unverified industry standard recovery rate for Povidone-Iodine, without demonstrating actual recovery on the firm's specific equipment. The validation also failed to address the carry-over of Iodine API or other potential residues. These observations indicate deficiencies in compliance with current Good Manufacturing Practices (GMP) regarding equipment design, maintenance, and cleaning validation. Marcus Research Laboratory, Inc. is expected to address these findings through comprehensive corrective and preventive actions to ensure the quality and safety of their manufactured drug substances.