The US Food and Drug Administration (FDA) on 13 April warned South American active pharmaceutical ingredient (API) manufacturer Proquimes SA Productos Quimicos Especializados SA for a multitude of good manufacturing practice (GMP) violations. The letter joins three others the agency has issued since the beginning of the year that are based solely on a records review and not onsite inspections.
Proquimes S A Productos Quimicos Especializados S.A Receives FDA Warning Letter