Median Actions on Inspections Reported By FDA

Under Section 902 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the FDA is required to annually publicly report information regarding certain statistics on inspections of facilities associated with the approval of drugs and devices and the impact that they might have had on delaying applications. The calendar year 2017 report has recently issued and the full report can be found here.

The report outlines the median times for the following metrics for both human drugs and devices:

• Median Time between Inspection Request and Beginning of Inspection
• Median Time between Beginning of Inspection and Issuance of Form FDA 483 Report
• Median Time between Issuance of Form FDA 483 Report to Regulatory or Enforcement Action
• Median Time between Regulatory or Enforcement Action to Resolution of Regulatory or Enforcement Action
• Application Delay due to Issuance of Withhold Recommendation

The narrative explains FDA’s interpretation and limitations of the data required to be reported and how it is reported.  The figures as noted above are all reported as median times – which mean half below and half above the figure provided.  What the report does not provide is the range of times for these activities.

Here are the figures for the various reports:

Median Time between Inspection Request and Beginning of Inspection

Median Time between Beginning of Inspection and Issuance of Form FDA 483 Report

Median Time between Issuance of Form FDA 483 Report to Regulatory or Enforcement Action

• No median days reported because there were none of these actions during CY 2017

Median Time between Regulatory or Enforcement Action to Resolution of Regulatory or Enforcement Action

For this item no median days are reported for both Groups NDAs and ANDAs as well as PMAs.  FDA explains:

Significant remediation efforts by the site and subsequent re-inspection by the FDA are usually required to determine if the CGMP issues have been resolved at a site classified as OAI; therefore, it is unlikely that a site will be inspected and a regulatory action (i.e. WL, IA, or Regulatory Meeting) taken, and resolution completed within a single calendar year. Further, only inspections with a CGMP surveillance component are reported here, as purely pre-approval inspections do not result in any of the enumerated regulatory actions. Finally, only CGMP inspections associated with facilities that have a pending NDA or ANDA are reported here.

During this CY 2017 reporting period, there were no regulatory or enforcement actions (i.e. WL, IA, or Regulatory Meeting) at establishments associated with a PMA submission. Therefore, there are no regulatory or enforcement action resolutions.

Application Delay due to Issuance of Withhold Recommendation

* This table “reports on the number of applications that were denied approval through the issuance of a CR letter due to a withhold recommendation because of the lack of compliance at a facility found during an inspection completed in CY 2017. This report includes applications that received a CR letter only because a facility named in the application was determined not to be in compliance as a result of an FDA inspection. Applications with any other inadequacies beyond facility non-compliance observed during an inspection are not included in this report.”

It will take a while to digest this information, but clearly the cost of non-compliance results in delay of approval of applications.  It is important to read the entire report to gain further insight into what all of the figures mean and how the FDA has defined its requirements under Section 902 of FDARA.