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:

Other ORA documents cab be found on the ORA home page.

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