CBER inspects manufacturing plants before it approves products, and thereafter, on a regular basis. The purpose of these inspections is to assess whether biological products are made in compliance with appropriate laws and regulations, and to assist in identifying any changes needed to help ensure product quality. CBER also may inspect clinical study sites to determine whether the studies are being carried out properly, and to ensure that accurate information is being submitted to the agency. CBER has a number of enforcement tools that may be used when a manufacturer or clinical researcher is in violation of FDA laws and regulations. | 
