Adultered Drug Production

FDA approval requires the scrutiny of the manufacturing process of a given drug as well as testing. After gaining FDA approval, companies are expected to closely adhere to the approved manufacturing process, and all manufacturing changes must be pre-approved by the FDA. Adulterated drug production occurs when pharmaceutical manufacturing companies alter or eliminate steps within the manufacturing process approved by the FDA. The drug produced by such means is deemed to be “adulterated” by the FDA.