FDA 483 - Fougera Pharmaceuticals, Inc. - August 10, 2022
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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.
ID · 313a4eac-daf4-4b86-b86a-1a2d3ba1847c