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What You Need to Know About FDA Remote Regulatory Assessments

The Remote Regulatory Assessment (RRA) was originally introduced in an April 2021 Guidance for Industry as a Remote Interactive Evaluation (RIE) and has since been broadened in scope to include more than RIE in the July 2022 Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry. The FDA further clarified the RIE process with the October 2023 Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Draft Guidance for Industry.  The RIE is considered one type of RRA by the Food and Drug Administration (FDA). Lessons learned during the COVID-19 pandemic resulted in FDA remote regulatory assessments becoming a permanent addition to the FDA toolkit to support regulatory decisions and oversight activities. This outcome was probably inevitable, as the pandemic forced everyone to rethink their paradigms about work and life activities.  

What is a Remote Regulatory Assessment?

A Remote Regulatory Assessment complements the FDA’s authority to conduct inspections, but it’s not considered an inspection itself, so the FDA will not issue either Form FDA 482, Notice of Inspection, or Form FDA 483, Inspectional Observations. The scope of RRAs can be extremely broad and the assessments can be either mandatory or voluntary. They are initiated by the FDA; currently, the industry is not permitted to request either RIE or RRA. If your establishment is contacted by the FDA regarding their intent to conduct an RRA, it’s important to treat the request as seriously as you would a normal Form FDA 482 Notice of Inspection. 

The FDA can, when significant issues are discovered during the RRA process, take other appropriate actions including an enforcement action. Therefore, we strongly recommend that FDA-regulated industries incorporate the RRA possibility into their inspection readiness activities. Below, we outline what else you need to know about FDA remote regulatory assessments to make sure you’re prepared: 

  1. The RRA process is different from an on-site inspection. In some cases, the request will be for electronic submission of specific documents or records. In other cases, the assessment may be conducted via audio or video conferences. There’s even the possibility of having to perform a virtual tour of the facility for the FDA. Because of the increased reliance on technology to convey information and the lack of personal face-to-face interaction, there’s a decrease in the ability of those providing the information to receive non-verbal feedback cues. The potential decrease in non-verbal feedback means that people need to proactively think of how the information can be perceived by the reviewer and mitigate any potential confusion as much as possible by having a richly documented record.  
  2. The FDA outlines a process for contacting the person on file to schedule a mandatory RRA or request an establishment to participate in a voluntary RRA. You can decline a voluntary RRA, but it may impact the timing of response to any filings that are pending with the agency. Ensure the RRA is scheduled for a date that gives the establishment enough time to prepare. You will need to confirm you have the technological ability to conduct the requested virtual walkthroughs of the plant or lab, have PDF copies available of all paper records that could be asked for during the RRA discussions, and have the subject matter expert(s) (SME) available and prepared to talk through the information in the records. 
  3. While no Form FDA 483, Inspectional Observations, will be issued, you may receive a written list of RRA observations. The FDA may also have a meeting with the establishment’s management to describe and discuss any observations in sufficient detail to ensure understanding and foster an appropriate response. As defined in the draft Industry Guidance, “RRA observations are defined as conditions and/or practices observed, in the judgment of the FDA employee(s) conducting the RRA, that indicate a potential violation of the laws enforced by FDA.”  A redacted list of identified issues may be subject to a public request under the Freedom of Information Act when the disclosure to the establishment is first made. You can respond during the meeting or in writing within 15 U.S. business days, and your responses or corrective actions will be considered before any further Agency action or decision. Your redacted responses are also available for public disclosure upon request.  
  4. The list of RRA observations is not a final Agency action or decision. However, evidence collected during the RRA may be used in support of any such action or decision. Following an RRA, the FDA may conduct an in-person inspection or take other appropriate actions, including an enforcement action, when significant issues are discovered. When the RRA is closed, the establishment will receive a written copy of the narrative portion of the RRA report. The report will ordinarily contain a summary of the information reviewed, conditions and practices found, and the observations identified. The report and supporting documents, with redactions, also become available for public disclosure upon request.

Ensuring a Successful FDA Remote Regulatory Assessment 

Preparing for RRA: Our recommendation is to treat the RRA just like it was an on-site inspection. As you prepare for the inspection, make sure your SMEs are prepped and ready to talk through the documents, and plan out the various contingencies needed for the expected paths the discussion may take. Dry run the discussions and presentations with industry experts unfamiliar with your processes and procedures to get a fresh view of them. Do those dry runs in the same manner as the RRA will be conducted, (i.e., not face-to-face in the same room). Take all misunderstandings seriously; if one person can get an incorrect impression, others can as well. You can also consider conducting a mock RRA using an independent person to play the role of the FDA as part of your inspection readiness preparations. 

During RRA: First, remember that you should stay calm during the RRA. Activate your support room and have your establishment’s IT staff on hand to address technology issues, as they may occur and will need to be quickly resolved by the IT team or mitigated by the presenters. Rely on your SMEs to walk the assessment team through the requested material. The FDA will likely give you a chance to commit to actions during the RRA to mitigate any issues that they recognize. Use these opportunities to immediately resolve these situations if you can easily do so by following your normal procedures, but do not take shortcuts that invariably lead to larger issues. By taking appropriate immediate actions, you may be able to avoid closing out the RRA with unresolved issues that will be reported back to the agency. If this isn’t feasible, commit to a thorough investigation of the issues and development of an appropriate Corrective Action and Preventive Action (CAPA) plan for resolution.  

Clarkston Can Help

It’s important that RRA preparation be included as part of your standard inspection readiness plans. Work with your organization to develop plans prior to receiving a request for, or notification of, an RRA, so you are fully prepared. This means taking the time to educate everyone in the organization to understand the RRA is as serious as an onsite inspection.  

If you’re not familiar with the RRA process, it may seem difficult to prepare. Clarkston Consulting has experts available to assist you with your RRA or other regulatory inspection preparations. 

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Tags: FDA Compliance