The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
This presentation: OSI_OSIS Metrics FY2023 (PDF - 1MB) provides annual inspection metrics for fiscal year 2023 for the compliance programs overseen by the Office of Scientific Investigations, or OSI and the Office of Study Integrity and Surveillance, or OSIS, in FDA’s Center for Drug Evaluation and Research (CDER). The vast majority of these inspections are conducted by FDA’s Office of Regulatory Affairs (ORA).
As FDA’s approval decisions are based on a review of the data submitted to the agency by an applicant, it is essential for the agency to ensure the integrity of the data submitted and to verify that the rights, health and welfare of those who participated in the studies were protected and that applicants continue to meet their obligations (e.g. for safety reporting) after approval.
Onsite inspection is one of many tools the FDA has for ensuring the integrity of data, the health and welfare of research participants, and the protection of public health.
Data source
Information was extracted from CDER's database Complis and other sources as noted.
Data conventions
These metrics are based on key events during the inspection process, including starting an inspection, issuing an inspection assignment, or issuing post-inspectional correspondence to the inspected party.
Differences in inspection counts when comparing data across varying sources may be the result of different tallying methods of inspection-related data.
For further information, please contact (301) 796-3150.
