FDA EIR - Unknown Company - January 08, 2020

An FDA inspection of CutisPharma, Inc. in Wilmington, MA, was conducted from January 8 to January 15, 2020. The inspection evaluated the company's readiness for release and stability testing of FIRVANQ (Vancomycin Hydrochloride Oral Solution) under the framework of 21 CFR Part 211, Good Manufacturing Practices.

The first key observation, referencing 21 CFR 211.165(e), highlighted a lack of established accuracy, sensitivity, specificity, and reproducibility for test methods. Specifically, the company lacked verification data for release and stability test methods for FIRVANQ, and failed to qualify essential laboratory equipment (e.g., incubators, stability chambers, refrigerators, freezers) necessary for these tests. Additionally, supporting data for microbiological testing was absent.

The second observation, citing 21 CFR 211.192, detailed inadequate customer complaint investigations. The Quality Unit failed to conduct investigations for several product issues, including leaking containers and hazy appearance, and did not examine retain samples for complaints involving foreign material or short fills. Furthermore, one investigation was not closed within the company's established timeframe.

Company management committed to submitting a written response to the FDA within 15 business days, outlining corrective and preventive actions to address the identified deficiencies and ensure regulatory compliance.