FDA Formalizes Remote Audit Practices via a New Guidance Document
(Thursday, July 28, 2022)
FDA’s practice of remote inspections, necessitated by the pandemic, is being made permanent via a new Guidance Document released this week. Remote inspections are known by many synonymous terms such as Remote Regulatory Assessment (RRA), remote interactive evaluations, remote record review, etc. Although FDA says that the RRAs do not replace on-site in-person inspections, and that the RRAs are technically “not inspections”, common sense says otherwise. The guidance describes the process FDA follows for deciding to pursue remote inspections, the criteria for requesting an RRA, the process, the expectations, and the outcome of an RRA. The remote inspections follow very similar process as that for conventional inspections with the review of the documents constituting the bulk of the FDA review, and includes virtual meetings, video tours, and list of findings. It does not lead to an FDA 483, but deficiencies identified during a remote inspection could lead to an on-site inspection and regulatory actions. The guidance is a good summary of what was broadly known for the last 2 plus years. It seems FDA inserted disclaimers differentiating RRAs from on-site inspections to quell any objections from the GAO which is repeatedly objected to remote inspections. It would be smart to not read the guidance literally but treat remote inspections the same as FDA’s on-site conventional inspections because for all intents and purposes, that’s what these are. This confirms another FDA practice normalized by the pandemic to be made permanent, just like remote work for FDA employees.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC