Free Access to FDA 483s

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

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 Affaires (ORA) is also publishing 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 at the "frequently requested or proactively posted compliance records" site
• Enforcement Reports, Recalls, Import Alerts, Import Refusals etc. can be found at 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.