FDA says it far exceeded its projections for inspections in FY2021

Regulatory NewsRegulatory News
| 22 November 2021 | By Michael Mezher 

In an update to its Resiliency Roadmap for FDA Inspectional Oversight, the US Food and Drug Administration (FDA) on Monday said that the number of domestic surveillance inspections it carried out in the second half of FY2021 was more than double the number it initially projected in the roadmap last spring.
 
In its initial Roadmap, FDA estimated that more than 15,000 domestic surveillance inspections that it planned to complete in FY2020 and FY2021 were postponed due to the pandemic, and that about 14% of those inspections could be conducted under a best-case scenario with a gradual transition to normal operations. In its initial Roadmap, FDA estimated that more than 15,000 domestic surveillance inspections that it planned to complete in FY2020 and FY2021 were postponed due to the pandemic, and that about 14% of those inspections could be conducted under a best-case scenario with a gradual transition to normal operations. (RELATED: FDA tallies pandemic inspection toll, issues new 'resiliency roadmap', Regulatory Focus 5 May 2021)

"This included 1,272 (10%) of the 12,285 remaining human and animal food domestic surveillance inspections and 851 (26%) of the 3,229 outstanding human and animal medical products inspections," FDA writes.
 
FDA now says it has exceeded those projections, as well as its projections for a swifter transition to normal operations, completing more than double the number of inspections it previously estimated it would be able to.
 
"FDA's development of new oversight approaches and expanded use of a variety of surveillance tools significantly contributed to the agency's ability to exceed these goals. This enabled the agency to provide oversight to as many facilities as possible, while utilizing our resources to protect consumers and patients and promote public health," FDA writes.
 
Instead of the roughly 2,200 facilities the agency predicted it could inspect by the end of FY2021, FDA managed to conduct 4,849 inspections.
 
"As of September 30, 2021, FDA has exceeded the Base-Case Scenario projections for FY21, completing more than twice as many domestic surveillance oversight activities than projected in the Roadmap. FDA’s development of new oversight approaches and expanded use of a variety of surveillance tools significantly contributed to the agency’s ability to exceed these goals. This enabled the agency to provide oversight to as many facilities as possible, while utilizing our resources to protect consumers and patients and promote public health," FDA writes.
 
The agency also noted progress toward conducting pre-approval inspections, which emerged as a concern among industry early on in the pandemic. When it issued its initial Roadmap, the agency said there were 68 applications for medical products that were "delayed solely due to a pending inspection or facility assessment," seven of which were deemed mission-critical.
 
"As of September 30, 2021, FDA conducted inspections or facility assessments that supported decisions for 30 of these delayed applications, including all seven mission-critical applications. Additionally, five of those applications outlined in the Roadmap are no longer delayed solely due to a pending inspection or facility assessment, as other factors have contributed to the delay," FDA says. In the months since, FDA says it has received another 31 applications that have met the criteria for prioritization and that it has completed inspections or facility assessments for four of those applications.
 
The agency says there are, as of 30 September 2021, 60 applications that are delayed solely due to a pending inspection.
 
For foreign inspections, FDA continues to focus on mission-critical inspections, though it did carry out some non-mission-critical inspection in FY2021. The agency says it conducted 124 foreign inspections in 23 countries between April and September 2021, 74 of which were related to human and animal medicinal products.
 
Additionally, FDA says it exceeded its target for compliance follow-up inspections during the remainder of FY2021. "In the Roadmap, FDA reported that, as of March 2021, we had conducted 49 of the 164 OAI follow-up inspections planned for FY21, leaving 115 to meet our performance target of 80%.10 As of September 30, 2021, FDA conducted 228 follow-up activities, including all 115 remaining follow-up inspections referenced in the Roadmap, accomplishing nearly double the performance target for FY21. Roughly 75% of firms that received follow-up inspections related to this performance target were found to have moved towards compliance during the follow-up inspection," FDA writes.
 
FDA

 

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