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 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.
In the world of pharmaceutical product manufacturing, market changes, financial concerns, innovations, competition, technological advances, and changes in business and manufacturing practices may often result in changes to the manufacturing process, making "adulterated" drug production more prolific. Penalties for such violations can be severe and may include hefty fines and penalties, possible jail time and potential loss of FDA approval and licenses.
If you, or your company, are facing charges of adulterated drug production, you will need a skilled and dedicated team of defense attorneys with experience and a proven record of success in achieving favorable outcomes for our clients. Call us at 888-984-5586 or Contact us for a free and confidential consultation with one of our experienced Pharmaceutical Crimes Attorneys.