23/24 September 2021
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: