Fougera Pharmaceuticals, Inc. – FDA 483, Nov 17, 2023

Fougera Pharmaceuticals, Inc., a non-sterile drug manufacturer in Hicksville, NY, was cited for failing to thoroughly review batch failures. Specifically, the firm did not investigate tube leakage found during the filling of Hydrocortisone Cream, nor did it perform root cause analysis or evaluate preventive actions. This indicates a deficiency in their deviation handling and quality control processes.