FDA Issues First Required Inspections Report, Covering 2017

In its first required inspection metrics report for 2017, FDA officials found a median time of 102 days between inspection requests by the FDA to a facility and the beginning of inspections, and a median of seven days between the beginning of a pre-approval inspection and the issuance of a Form 483.

The median times were longer for both the time between the issuance of a 483 and enforcement action (191 days) and between the issuance of a 483 and a regulatory meeting (169 days), according to the report.

The annual report is newly required under last year’s reauthorization of the agency’s user fees. The agency said it interprets the law to require it to publish information with respect to NDA and ANDA approvals as well as their supplements. The agency’s interpretation limited the report to Official Action Indicated meetings, omitting those it classified as Voluntary Action Indicated.