FDA 483 - Marcus Research Laboratory, Inc. - September 02, 2022

An FDA inspection of Marcus Research Laboratory, Inc. in St. Louis, MO, revealed nine significant observations related to the manufacturing of povidone-iodine APIs. Deficiencies were noted in process validation, equipment qualification, facility maintenance, cleaning procedures, cleaning validation, change control, method validation, batch record documentation, and stability sample storage. These issues collectively indicate a lack of robust quality systems and controls, potentially impacting the identity, strength, quality, and purity of the APIs produced.