Updated FDA guidance regarding onsite inspections

The US Food & Drug Administration (FDA) has recently updated a Q&A guidance document detailing the alternative actions the agency will undertake when onsite inspections are infeasible due to the COVID-19 pandemic.

Whilst the answers to many questions have been slightly reworded to improve readability, their content remains the same. The exception is question 6, the answer to which contains new information and is now significantly more detailed. Question 6 covers whether applications including sites that cannot be inspected due to pandemic related travel restrictions will automatically receive a complete response (CR) letter. In the answer, the FDA states various actions that may occur in said applications.

Firstly, the agency states its plans to approve an application if the available information supports the adequacy of the facilities and the sites named in a pending application.

Where the available information from a prior inspection or the use of alternate tools raises concerns about the adequacy of a site or the responses to outstanding issues are not sufficient and an inspection cannot be completed due to travel restrictions, then the FDA would issue a CR letter with facility or site related deficiencies.

A CR letter without facility or site relate deficiencies will be issued where an inspection is necessary due to insufficient information being available to make a determination on the acceptability of a facility or site. In this letter, the FDA will include any other deficiencies and a comment stipulating the need for an inspection to support approval of the application due to the lack of relevant information.

Additionally, in scenarios where insufficient information makes an inspection necessary but no other deficiencies have been identified, then the FDA may defer action (miss the goal date) on an application. In this situation the FDA will inform the applicant if this is the case and there will be no need for the applicant to schedule an inspection to support application approval.

Furthermore, an additional question (how does the FDA intend to prioritize inspections as travel restrictions are eased or lifted?) has been included in the revised guidance. In the answer the agency details that where alternative tools are not available or not satisfactory, the FDA will use a risk-based approach to prioritise inspections. This will include considering:

  • How product availability could impact public health
  • Investigator safety
  • Specific travel restrictions in the location of the facility/site.

All aforementioned considerations will be balanced with application goal dates and the efforts to reduce backlogs of assigned inspections.

The updated guidance has been released in tandem with a separate document highlighting the use of alternative tools such as remote interactive evaluations.

To view the updated Q&A guidance, click here.