FDA EIR - Unknown Company - January 08, 2020

An FDA inspection of CutisPharma, Inc. in Wilmington, MA, occurred from January 8 to January 15, 2020. The pre-approval inspection assessed the firm's readiness for release and stability testing of FIRVANQ (Vancomycin Hydrochloride Oral Solution) under NDA 208910. Two primary observations were noted for non-compliance with regulatory frameworks.

Observation 1 (21 CFR 211.165(e)) identified a lack of data to support the verification of microbiological release and stability test methods. Additionally, essential laboratory equipment, including incubators, stability chambers, refrigerators, and freezers, remained unqualified for their intended use in these critical tests. This indicated a failure to adequately establish test method accuracy, sensitivity, specificity, and reproducibility.

Observation 2 (21 CFR 211.192) revealed deficiencies in the Quality Unit's complaint handling process. The firm failed to conduct investigations for multiple customer complaints regarding product defects like leaking containers and hazy appearance. For other complaints, such as those involving foreign material or short fills, retain samples were not examined. Furthermore, at least one investigation exceeded the firm’s established closure timeframe.

CutisPharma's management committed to submitting a written response to the FDA within 15 business days to address these findings.