FDA Seeks Input on Redesign of Form 483

By Daniel R. Matlis

As part of the FDA’s transparency initiative, the agency seeks input from its constituents on whether inspectional observations reports (form 483) should be re-designed to make inspection findings available to the public quickly.

Form FDA-483 lists observations made during the inspection of a firm. Responding to Freedom of Information Act requests for 483s, often takes a lot of time due to the need to redact non-public information, such as trade secret and confidential commercial information, from the report.

The Agency is seeking to streamline the process required to make 483 findings available. To this end, FDA would like to re-design the inspection reports (483s) to include a summary or key findings page that could be made available to the public quickly. FDA would still review the full inspectional observation reports to redact any non-public information. 

To provide input to the agency on the re-design of Form 483, visit:  http://bit.ly/7ytaHG

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