FDA clarifies potential actions when onsite inspections are infeasible
The US Food and Drug Administration (FDA) on 17 May revised its question-and-answer guidance on inspections during the COVID-19 pandemic to clarify the regulatory actions it plans to take when it cannot conduct an onsite inspection of a facility.FDA announced that while the pandemic continues to restrict onsite inspections, the agency “intends to continue using alternative tools to evaluate facilities.” FDA continues to conduct onsite inspections for those products deemed “mission critical.”
The newly revised guidance updates an earlier version issued in August 2020 and follows a recent guidance on the agency’s use of alternative tools, such as remote interactive evaluations, during the pandemic. (RELATED: FDA issues pandemic inspections FAQ guidance, Regulatory Focus 19 August 2020; FDA issues long-awaited pandemic remote inspections guidance, Regulatory Focus 14 April 2021).
The agency states that the document is “intended to provide information regarding common queries related to inspections for facilities manufacturing pharmaceutical products and sites involved in the conduct of clinical, analytical, and nonclinical studies.”
FDA’s ability to conduct inspections and its use of alternative tools in place of onsite inspections have been topics of concern for both industry and those overseeing the agency. Despite efforts to mitigate the impact of conducting fewer inspections and resorting to document reviews where possible, the Government Accountability Office (GAO) has warned that FDA faces a looming inspection backlog, which the agency plans to address via a resiliency roadmap released earlier this month. (RELATED: FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 9 March 2021; FDA tallies pandemic inspection toll, issues new 'resiliency roadmap', Regulatory Focus 5 May 2021).
The Q&A addresses how inspections have been impacted by COVID-19, the types of inspections FDA deems “mission critical,” and its criteria for issuing complete response (CR) letters following an inspection.
The new updates to the guidance document clarify which actions FDA may take when it cannot conduct a physical inspection.
When the available information supports the adequacy of the facilities and sites named in a pending application, and no deficiencies have been identified, FDA may approve the application.
FDA may issue a CR letter for facility- or site-related deficiencies in cases where the available information from a prior inspection or other source identifies facility or site deficiencies, but an inspection cannot be completed due to travel restrictions. In this case, the CR letter may include additional deficiencies identified by the assessment team.
If an inspection is necessary because there is insufficient information currently available to make a determination on the acceptability of a site, FDA may issue a CR letter without facility or site deficiencies. Any facility or site issue will be referred to in a comment in the CR letter; the CR letter will contain other deficiencies that were identified by the assessment team.
FDA may also defer action in cases where an inspection is deemed necessary but there is a lack of information about the facility or site. This action is taken in those case where no deficiencies have been identified and the application otherwise satisfies the requirements for approval; the revised guidance acknowledges that this action means that FDA has missed its goal date for action on the application
FDA states in the guidance that it would “not automatically” issue a CR letter if it cannot conduct an inspection because of travel restrictions and that “decisions regarding applications will be based on the totality of the information available to FDA, including information obtained from use of the alternative tools.”
The agency also says that manufacturers may submit applications for a sites located in areas impacted by COVID-19: “Reference in an application to a facility in a region impacted by COVID-19 travel restrictions does not preclude submission to FDA."
The revised guidance will be in effect for the duration of the public health emergency.
COVID-19 inspections guidance
Remote inspections guidance
