How to get free Access to FDA 483s
Many people in the pharmaceutical industry are aware of the fact that Warning Letters issued by the US Food and Drug Administration (FDA) are published on the FDA Website.
But the Office of Regulatory Affairs (ORA) also publishes other copies of ORA domestic inspection and related records. This is done either proactively at ORA's discretion or because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996.
Here is an overview on what is available:
- 483 observations are best to be seen on the "frequently requested or proactively posted compliance records" site
- Enforcement Reports, Recalls, Import Alerts, Import Refusals etc. can be found on the data sets page
- Warning Letters are accessible on a dedicated page for Warning Letters
- Establishment Inspection Reports can be searched in the ORA FOIA Electronic Reading Room
- Persons currently debarred pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b) are listed in the FDA Debarment list.
Other ORA documents cab be found on the ORA home page.
Related GMP News
01.10.2025Alternative Inspection Methods of the FDA
24.09.2025FDA issues final Guidance on Remote Oversight Tools
24.09.2025Four Warning Letter concerning CAPA and Root Cause Analysis published
03.09.2025FDA Report on the State of Pharmaceutical Quality
27.08.2025Bizarre Findings in FDA Warning Letters
27.08.2025FDA Warning Letter with a diverse List of Deficiencies