After a Series of False Starts, FDA Resumes Domestic Inspections

FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates.

This announcement follows a series of inspection pauses, including one announced on January 19, and one announced on January 4.

Importantly, even while many inspections were paused, the Agency still conducted mission-critical domestic and foreign inspections, and continued to oversee the production of foods, drugs, medical products, and tobacco by conducting remote assessments and import operations surveillance, as it has done throughout the pandemic.

With respect to foreign inspections, FDA will continue planned foreign inspections in countries that have “received country clearance and are within the Center for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation.” FDA also stated that it is planning for additional foreign inspections “with an anticipated goal of conducting foreign prioritized inspections starting in April.”

FDA is also continuing its remote foreign supplier verification program (FSVP) activities for human and animal foods. Furthermore, states that contract with FDA under one of FDA’s contract programs have discretion to make inspection decisions based on their local information. For example, under the Human Food Inspection Program, FDA works collaboratively with state agencies for the inspection of food manufacturers and processors.

FDA is eager to resume its inspection program both at home and abroad. Last year, the Government Accountability Office (GAO) issued a report in March 2021 highlighting FDA’s inspection backlog. GAO reported that FDA had only conducted three foreign drug manufacturing inspections in 2020—significantly less than in recent years—and stated that the agency must come up with a plan to address the looming inspections backlog. While FDA was able to make some progress in 2021 (124 inspections of regulated firms performed between April and November 2021), the number of foreign inspections remains way under pre-pandemic levels (e.g., 16,920 inspections of regulated firms were completed in FY 2019).

What Should Regulated Firms Expect in 2022?

• Barring future COVID-19 inspection spikes, firms should be ready for a visit from the FDA. After a long COVID-19 pause, FDA began in earnest last year to restart its inspection program, including routine inspections. Quality records generated during the COVID-19 pandemic are ripe for review by FDA.
• Firms should revisit their quality programs and systems to verify compliance. During the course of the pandemic, there may have been a need to deviate from or modify procedures to deal with some of the pandemic’s unique challenges. Firms should ensure that all deviations are documented, thoroughly evaluated, and that adequate corrective and/or preventative actions are put in place.
• Ensure that quality staff and subject matter experts are “inspection ready.” Practice can help ensure a smooth inspection. Firms should consider engaging third parties “acting in the role of an FDA investigator” to pressure test key quality subsystems and issues. Personnel should be up to date on the firm’s inspection readiness procedures so that all personnel, including personnel who may have joined during the pandemic and never experienced an inspection, are clear on inspection processes (e.g., front room/backroom setup).
• Firms needing FDA inspections for approval of applications or supplements, or to resolve prior inspectional deficiencies, should consider contacting FDA to see if an inspection can be prioritized. When FDA last resumed its inspections, it was able to proceed quickly, exceeding its expected inspections by more than 200%. According to the Agency, “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 [its] goals. This enabled the agency to provide oversight to as many facilities as possible, while utilizing… resources to protect consumers and patients and promote public health.” Thus, if history repeats itself, FDA should commence its fast progress through its still-substantial backlog.

How We Can Help

Morgan Lewis has travelled the world conducting FDA inspection readiness assessments and has defended regulated firms before FDA inspections. Where inspections result in observations, Morgan Lewis helps companies draft strategic corrective action plans and responses to assist in preventing further enforcement while considering the least burdensome approaches.

Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Jacqueline R. Berman
Dennis C. Gucciardo
Angela Silva