FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system.[1]

Specifically, FDA has established a COVID-19 Advisory Rating System (COVID-19 Advisory Level), under which sites will be selected for inspection based on the state reopening phase and county level COVID-19 statistics measuring infection trends and intensification. The rating will be used by FDA to identify permissible FDA inspectional activities within specific geographic regions as follows:

1. Mission critical inspections only
2. Inspections with agency precautions to protect vulnerable staff
3. Resumption of all regulatory inspections

To move from one inspectional phase to the next, FDA states that it must see decreasing new COVID-19 infections and hospitalizations in a given area. FDA will also take into account the availability of local services, such as public transportation.

With this rating system in place, FDA is working toward restarting inspections during the week of July 20. With the exception of retail tobacco inspections, prioritized domestic inspections will be preannounced (a notable change from past FDA practices), so that both FDA and the inspected firm may ensure a safe inspectional environment and that appropriate staff are on site. Inspectors will also be outfitted with personal protective equipment (PPE).

Impact to Regulated Firms

We suspect that FDA will work slowly and methodically in resuming its inspection program. Considering the backlog of onsite inspections that firms have been requesting to support product submissions or to close out enforcement actions, it may take some time before FDA resumes performing routine surveillance inspections. With this FDA announcement, firms that are in need of an inspection should proactively reach out to FDA to inquire about the possibility of being included on an inspection schedule.

With the resumption of FDA inspections and FDA’s new procedures, all firms should take this opportunity to reassess inspection readiness. Firms should consider the following checklist in preparation of a potential FDA inspection:

• Review documentation routinely reviewed during inspections (e.g., complaints, batch records, validation reports and protocols, corrective and preventative actions, adverse event reporting records, supplier qualification files, etc.).
• Review inspection procedures and plans to ensure that they reflect the realities of performing an onsite inspection during the COVID-19 pandemic.
  • Confirm the location of documentation that may be requested during an inspection to help ensure that records can be provided to the investigator in a timely manner.
  • Confirm the availability of subject-matter experts that may be called on to explain documentation.
• Conduct training with company personnel on inspection procedures, focusing on any special requirements due to the COVID-19 pandemic (e.g., interacting with an investigator, use of PPE during an inspection, and maintaining social distancing during the inspection).
• Review and update procedures for inspector security, sanitation, sterility, and infection control. Specifically, firms should request that inspectors comply with reasonable facility visitor procedures, which may include signing in and out to enable contract tracing, the use of PPE, and potentially other health checks to the extent required for visitors more generally (per FDA’s Inspection Operations Manual, inspectors are required to follow an inspected firm’s sanitation and sterility program).

While the resumption of domestic inspections using a risk based program indicates what may be a new normal for the agency, a number of questions still remain. By example:

• Foreign Inspections: Many regulated firms are located outside the United States (e.g., as of August 2019, 72% of active pharmaceutical ingredient facilities and 53% of finished dosage form facilities are manufactured outside of the United States). While FDA has other tools within its enforcement regime (e.g., sampling at the port of entry) to monitor these products, many activities require preapproval onsite inspections (e.g., manufacturing site change supplements for medical products approved through the Humanitarian Device Exemption (HDE), Premarket Approval (PMA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA) route). It’s unclear whether FDA will create a similar risk based program for resuming foreign inspections.
• State and Local Laws: It is also unclear how FDA’s procedures will take into account state COVID-19 requirements, including state visitor quarantine rules.

Given the above, FDA’s inspection processes will likely evolve, necessitating that regulated firms continue to maintain inspection readiness while also monitoring the likelihood of receiving an in-person inspector visit.

HOW WE CAN HELP

Morgan Lewis helps companies around the world prepare for FDA inspections, assist and defend inspections, and respond to inspectional observations. We provide legal and regulatory strategy and counsel on product submissions, product liability risks, and ongoing regulatory compliance.

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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
Michele L. Buenafe
Dennis C. Gucciardo