Tell Us Your Ideas: How Should FDA Inform the Public About Inspection Results
FDA conducts many inspections. A completed Form FDA-483 lists observations made during an inspection of a firm. Responding to Freedom of Information Act (FOIA) requests for these reports of inspectional observations, however, often takes a lot of time because of the need to redact non-public information, such as trade secret and confidential commercial information, from the inspection report.
FDA seeks input on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly. Disclosure of full inspectional observation reports would still require the same review for non-public information as it does now.
Does this sound like a good idea? If so, what would be key points to be included in the summary page? What, if any, other ways can the agency use to provide results of inspections to the public quickly?
We look forward to your feedback.
Transparency Task Force