Marcus Research Laboratory, Inc. – FDA 483, Jul 20, 2021

Marcus Research Laboratory, Inc. in Saint Louis, MO, a human and animal drug manufacturer, was cited for significant deficiencies in its quality system, including releasing API without ensuring quality after incidents, inadequate quality unit independence, and poor equipment maintenance. The inspection revealed issues with batch record completeness, lack of cleaning validation, improper container labeling, and insufficient GMP training for personnel. These observations indicate a systemic failure to adhere to good manufacturing practices for Povidone Iodine API.