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Where can I find FDA 483 reports?

Examples of recently issued 483s are available in ORAs Electronic Reading Room. Questions regarding Inspection Observations may be directed by email to FDAInspectionsObservations@fda.hhs.gov.

Are FDA documents public?

Obtaining Public Information Certain documents that are prepared for public distribution--such as press releases, consumer publications, speeches, and congressional testimony--are available from FDA without having to file a Freedom of Information Act (FOIA) request.

Are FDA 483 observations public?

Theoretically, Form FDA 483s are public information and, thus, are available through the FDAs Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone.

Are FDA inspection reports public?

FDA discloses a segment of inspection information to help improve the publics understanding of how the FDA works to protect the public health.

What is a 483 FDA code?

When is a Form FDA 483 issued? A Form FDA 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic (FDC) Act and other Acts or regulations.