FDA 483 - Vilvet Pharmaceuticals Inc. - January 10, 2020

Vlivet Pharmaceuticals Inc. in Chester Springs, PA, received a Form 483 with three observations during an inspection from October 2019 to January 2020. The inspection revealed significant deficiencies in laboratory controls, specifically regarding stability testing for drug products like Phenazopyridine tablets, and a lack of adequate procedures for supplier qualification and complaint handling within the quality control unit. These issues indicate a failure to ensure drug product quality and purity and to maintain proper quality system documentation.