FDA EIR - Azurity Pharmaceuticals, Inc. - April 19, 2019

A U.S. Food and Drug Administration (FDA) surveillance inspection of CutisPharma, Inc. was conducted from April 5-19, 2016. This inspection, carried out under Compliance Programs #7353.001 for Post Marketing Adverse Drug Experience (PADE) and #7356.021 for Drug Quality Reporting System (DQRS), served as a follow-up to a January 2014 inspection. The previous inspection had cited five significant deficiencies, including inadequate complaint investigation, deficient ADE reporting procedures, lack of written quality control responsibilities, and insufficient cGMP training. The current inspection confirmed that these prior issues had been successfully rectified.

While no new formal FDA Form 483 observations were issued, the inspection identified three critical discussion points. These included an ambiguous definition of "Day 0" for receiving adverse drug experiences and complaints within the company's standard operating procedures, the absence of clear timeframes in quality agreements for contract manufacturers to report ADEs to CutisPharma and complete corrective and preventive actions, and an oversight in ensuring employees were trained on the most current customer complaint procedures. Additionally, the inspection addressed ongoing DQRS complaints concerning potential medication errors due to similar labeling for Vancomycin products. CutisPharma management acknowledged these concerns and initiated immediate revisions to relevant procedures and agreements, committing to complete all necessary corrections.