The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm's compliance with regulations and the Food, Drug and Cosmetic Act. Inspections are one of many ways FDA protects the public health.
The Agency is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance. For this data set, FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken. Therefore, this database does not represent a comprehensive listing of all conducted inspections and should not be used a source to compile official counts.
Inspections are classified (see Inspection Classifications) to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance. During the Agency assessment, classifications may be subject to change after a review of all relevant information. To maintain current knowledge of a firm's compliance status, it may be important to recheck the Inspections Database for updates.
Questions regarding the Inspections Database may be directed by email to FDAInspectionsClassifications@fda.hhs.gov.
Please note: The Inspection Classifications Database has been updated as of July 27th, 2016. This updated version discloses FDA inspections that due to a technical issue were excluded from the previous version, which was published in June 2016. The Inspection End Date range remains the same as the previous version (i.e., 10/1/2015 through 3/31/2016).
Inspections Classification Database and Search
Inspection classifications listed in this report reflect the compliance status when the report was generated and may not represent the final Agency determination. FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken.