FDA 483 - Vilvet Pharmaceuticals Inc. - June 27, 2018

Vilvet Pharmaceutical, a manufacturer in Chester Springs, PA, was cited for significant deficiencies in its quality control unit during an FDA inspection. The firm lacks comprehensive written procedures and adequate oversight for critical functions, especially concerning its contract manufacturer of prescription drugs. This includes failures in reviewing batch records, assessing stability data, handling complaints, and approving various validation protocols, indicating a serious breakdown in quality assurance.