FDA Announces Final Guidance for Remote Assessments
The U.S. Food and Drug Administration (FDA) has released its most comprehensive guidance related to its use of Remote Regulatory Assessments (RRAs). The document serves as a wide-ranging FAQ for RRAs, building upon the agency’s late 2023 announcement that it would be expanding the use of Remote Regulatory Assessments (RRAs) beyond the COVID-19 pandemic.
The guidance, which cements the FDA’s interest in expanding the use of RRAs, outlines important answers to key questions life sciences manufactures will have about the practice, including:
Here are some quick answers for the most crucial RRA questions.
Are RRAs different than inspections?
Yes, but don’t relax just yet. According to 704(a)(1) and 704(a)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C), an inspection involves designated officers or FDA employees physically entering premises. As such, an RRA, which is completely digital, is not an inspection by law. However, under section 805 of the FD&C, records obtained during and after an RRA can be used to determine compliance.
Expert tip: treat any RRA as seriously as you treat a physical inspection.
Why is the FDA increasing the use of RRAs?
The guidance notes that RRAs are used when the agency deems them appropriate, including times when:
The FDA will use a risk-based approach to determine when to deploy RRAs, and will consider:
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Are RRAs mandatory?
Sometimes. The FDA categorizes RRAs as mandatory or voluntary. Your response may change depending on this categorization; however, it’s recommended a voluntary RRA be treated as mandatory.
What response is required after an RRA?
Like an inspection, an RRA will finish with a closeout meeting between company representatives and the FDA. Here, the FDA may provide a written record of observations and describe, in enough detail, ways the organization should respond. The FDA notes that these written observations may be subject to Freedom of Information Act requests and as such, become publicly available.
The FDA encourages establishments to respond to a closeout meeting within 15 days of the closeout meeting. Responses and corrective actions will be considered before further regulatory action.
Expert note: Establishment responses are also publicly available, so they should be thorough.
Will a Form 483 be issued following an RRA?
No, Form 483s will not be issued during RRAs, but with both the written report and the establishment’s response being publicly available, it’s highly recommended that an organization does not take an RRA any less seriously than an inspection.
Increasing scrutiny at home and abroad
The use of RRAs isn’t the only change the FDA has announced to its regulation of manufacturing facilities. In May 2025, the FDA released its intention to increase unannounced inspections of overseas pharmaceutical manufacturing facilities that serve the U.S. market.
This is in line with the Trump administration’s stated goals of increasing domestic pharmaceutical production. Typically, overseas facilities have been given long advanced notice of an upcoming inspection. Oftentimes, this notice was longer than domestic manufacturing which could have short or even no-notice inspections.
The FDA’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program began in 2022 focused on sites in India and China. This announcement builds upon the work of that program and is expected to greatly expand its use.
On average, the FDA conducts 12,000 domestic inspections and 3,000 foreign inspections annually. Despite more advanced notice of inspections, foreign facilities are found deficient twice as much as domestic facilities, according to the FDA’s press release.
How to prepare for RRAs and be inspection-ready
Since RRAs are primarily a digital exercise, organizations that already have their quality and validation documentation in digital formats will be better ready to respond. Assessors will be able to request data and documentation, even when not onsite. Paper-based processes will then require scanning and collating; a significant time sink for an organization.
The need for digital validation is even more dire when it comes to physical inspections, especially unannounced. It provides more confidence for core compliance issues, such as data integrity concerns, and greatly assists in finding relevant material requested by investigators.
Kneat’s Collections Feature enables companies to easily add pre-approved documents to virtual War Room. Making investigations and assessments seamlessly digital.
Kneat Gx is the chosen digital validation platform for 8 of the Top 10 global life sciences companies. It’s proven to not only reduce validation cycle time by 50% or more, but also assist in CAPA change control processes, streamlining them by over 80%.
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