FDA 483 - Fougera Pharmaceuticals, Inc. - August 10, 2022

Fougera Pharmaceuticals, Inc. in Hicksville, NY, received a Form 483 with two observations related to manufacturing controls. The inspection revealed deficiencies in equipment cleaning validation and a lack of adequate written procedures for production and process controls. These issues included an incomplete cleaning validation study for a bottle filler and problems with process validation and operator actions during line stoppages, indicating potential risks to drug product quality.