FDA is responsible for overseeing the safety and effectiveness of human drugs that are marketed in the United States, whether they are manufactured in foreign or domestic establishments. Foreign establishments that market their drugs in the United States must register with FDA. As part of its efforts to ensure the safety and quality of imported drugs, FDA is responsible for inspecting foreign establishments whose products are imported into the United States. The purpose of these inspections is to ensure that foreign establishments meet the same manufacturing standards for quality, purity, potency, safety, and efficacy as required of domestic establishments. Requirements governing foreign and domestic inspections differ. Specifically, FDA is required to inspect registered domestic establishments that have been previously approved to market their drugs in the United States every 2 years, but there is no comparable requirement for inspecting foreign establishments. FDA does not have authority to require foreign establishments to allow the agency to inspect their facilities. However, FDA has the authority to conduct physical inspections of the imported product or prevent its entry at the border. Within FDA, CDER sets standards for and evaluates the safety and effectiveness of prescription drugs and over-the-counter drugs. Among other things, CDER requests that ORA inspect both foreign and domestic establishments to ensure that drugs are produced in conformance with federal statutes and regulations, including current GMPs. CDER requests that ORA conduct inspections of establishments that produce finished drug products. CDER also requests inspections of those that produce bulk drug substances, including the active pharmaceutical ingredients (API) used in finished drug products. These inspections are performed by investigators and laboratory analysts. ORA conducts two primary types of inspections: Preapproval inspections of domestic and foreign establishments are conducted before FDA will approve a new drug to be marketed in the United States. These inspections occur following FDA’s receipt of an NDA or ANDA and focus on the manufacture of a specific drug product. Preapproval inspections are designed to verify the accuracy and authenticity of the data contained in these applications and ensures that the manufacturer of the finished drug product, as well as each manufacturer supplying a bulk drug substance used in the finished product, manufactures, processes, and packs the drug adequately to preserve its identity, strength, quality, and purity. Postapproval GMP surveillance inspections are conducted to ensure compliance with applicable laws and regulations pertaining to the manufacturing processes used by domestic and foreign establishments in the manufacture of finished drug products marketed in the United States and bulk drug substances used in the manufacture of those products. These inspections focus on a manufacturer’s systemwide controls for ensuring that drug products are high in quality. Systems examined during these inspections include those related to quality control, production, and packaging and labeling. These systems may be involved in the manufacture of multiple drug products. FDA allocates funds to ORA to carry out preapproval and postapproval inspections of foreign and domestic establishments. ORA develops an annual work plan and a budget that estimates human resources available to conduct activities related to foreign inspections. ORA also develops estimates for inspections of domestic establishments. Typically, ORA investigators and laboratory analysts travel abroad for about 3 weeks at a time, during which they inspect approximately three establishments. Each establishment inspection typically lasts a week, with 1 day of each week set aside for documenting the inspection or for extending the inspection, if necessary. CDER uses a risk-based process to select some domestic and foreign establishments for postapproval GMP surveillance inspections. According to an FDA report, the agency developed the process after recognizing that it did not have the resources to meet the requirement for inspecting domestic establishments every 2 years. The process uses a risk model to identify those establishments that, based on characteristics of the establishment and of the product being manufactured, have the greatest public health risk potential should they experience a manufacturing defect. (See table 1 for a description of the risk-based site selection model used by FDA in fiscal year 2007.) For example, FDA considers the risk to public health from poor quality over-the-counter drugs to be lower than for prescription drugs, and consequently establishments manufacturing only over-the-counter drugs receive a lower score on this factor than other manufacturers. Through this process, CDER annually prepares a prioritized list of domestic establishments and a separate, prioritized list of foreign establishments. CDER began applying this risk-based process to domestic establishments in fiscal year 2006 and expanded it to foreign establishments in fiscal year 2007. FDA relies on multiple databases to manage the foreign drug inspection program. FDA assigns unique numeric identifiers to establishments, known as the FDA establishment identifier (FEI) number. An FEI number could be assigned at the time of registration, importation, or inspection. DRLS contains information on foreign and domestic drug establishments that have registered with FDA. Establishments that market their drugs in the United States must register with FDA. These establishments provide information, such as company name and address and the drug products they manufacture for commercial distribution in the United States, on paper forms that are entered into DRLS by FDA. OASIS contains information on drugs and other FDA-regulated products imported into the United States, including information on the establishment that manufactured the drug. The information in OASIS is automatically generated from data managed by U.S. Customs and Border Protection, which are originally entered by customs brokers based on the information available from the importer. Each establishment is assigned a manufacturer identification number that is generated from key information entered about an establishment’s name, address, and location. FACTS contains information on FDA’s inspections of domestic and foreign drug establishments. FDA investigators and laboratory analysts enter information into FACTS, following completion of an inspection. According to DRLS, in fiscal year 2007, China and India had more establishments registered to manufacture drugs for the U.S. market than any other country. Other countries that had a large number of establishments registered to manufacture drugs for the U.S. market in this year were Canada, France, Germany, Italy, Japan, and the United Kingdom. (See fig. 1.) These countries are also listed in OASIS as having the largest number of manufacturers importing drugs into the United States. FDA does not know how many foreign establishments are subject to inspection; including the number of establishments that are registered and whose products are currently imported into the United States and establishments that are not required to register but whose products are ultimately used in drugs that are marketed here. Instead of maintaining a list of such establishments, FDA relies on information from several databases that were not designed for this purpose. DRLS, established in 1991, is intended to list the establishments registered that manufacture drugs for the U.S. market. However, requirements for the registration of foreign establishments were not implemented until 2002. FDA expected that requiring foreign establishments to register would provide it with a comprehensive list of such establishments. In fiscal year 2007, approximately 3,000 foreign establishments were registered with FDA that manufactured human drugs, biologics, or veterinary drugs; FDA was unable to determine from this database the number of registered establishments specifically manufacturing human drugs. DRLS provides FDA with some information about establishments subject to inspection, but contains inaccuracies and does not provide a complete count. FDA officials told us that the count of registered foreign establishments in DRLS does not reflect the actual number whose products are being imported into the United States for several reasons. First, foreign establishments may register with FDA, whether or not they actually manufacture drugs for the U.S. market. FDA officials told us that this is made more likely by the fact that FDA does not charge foreign establishments a fee to register. FDA officials pointed out that some foreign establishments register because, in foreign markets, registration may erroneously convey an “approval” or endorsement by FDA. Second, foreign establishments may not renew their registration information, although they are required by FDA to do so annually. Agency officials told us that if foreign establishments stop manufacturing drugs for the U.S. market or go out of business they may not report the change to FDA, even though it is required. FDA officials told us that the agency does not routinely verify the information provided by the establishment to ensure that it is accurate or confirm that the establishment actually manufactures drugs for the U.S. market. FDA does not know how many foreign establishments are erroneously registered. Third, foreign establishments that manufacture APIs are not required to register if their products are not directly imported into the United States. OASIS also provides FDA with some information about establishments subject to inspection, but this database contains inaccurate data on the count of foreign establishments manufacturing drugs imported into the United States. According to OASIS, 6,760 foreign establishments manufactured drugs that were imported into the United States in fiscal year 2007. However, FDA officials told us that errors in data entry result in inaccurate counts of establishments whose drugs are imported into the United States. FDA officials told us that if information about an establishment—such as its name—was entered by customs brokers incorrectly, a new manufacturer identification number, and thus a new FEI number, could be assigned to an establishment that already has an FEI number. For example, a customs broker may enter an establishment’s name slightly differently from the way it is displayed in OASIS, such as using “Inc.” instead of “Incorporated,” which would lead to the creation of a second FEI number for the establishment. Therefore, a single establishment may be counted more than once in OASIS, which would result in an artificially high count of foreign establishments importing drugs into the United States. FDA officials acknowledge this problem but were unable to provide us with an estimate of the extent of that error. In addition, the agency does not have a process for systematically identifying and correcting these errors. To mitigate this problem, the officials told us that FDA has provided regional training to brokers as a way to improve accuracy. FDA officials also told us that the agency is pursuing a new government-wide initiative that would address this problem by providing a unique identifier for each foreign establishment involved in the import supply chain.