FDA 483 - Marcus Research Laboratory, Inc. - December 06, 2019

An FDA inspection of Marcus Research Laboratory, Inc., an API manufacturer in St. Louis, Missouri, revealed significant deficiencies across its operations. The firm failed to adhere to quality control procedures, including proper OOS investigations and document control, and lacked adequate process validation and stability testing methods. Additionally, the facility exhibited poor maintenance, labeling errors, and insufficient contamination prevention measures, indicating a broad failure to meet GMP standards.