FDA’s Expanded RRAs Make Every Facility More Susceptible to “Assessment”

During the pandemic, FDA adapted its operations to allow for the use of remote regulatory assessments (RRAs) to assess establishments and their regulatory compliance. The more than 1,470 domestic and 600 foreign entity RRAs FDA performed over the last two years was seen to have had enough value that the agency has proposed to extend their use beyond the pandemic for certain scenarios and all types of FDA-regulated products.

As defined by FDA, an RRA is the remote examination of an FDA-regulated establishment and/or its records to evaluate its regulatory compliance. To detail how the RRAs may be used and to promote consistency in the way they are conducted, FDA published draft guidance in July, “Conducting Remote Regulatory Assessments Questions and Answers.” Although the guidance does not change the core requirements of inspections and pre- and post-market authorities, it does allow for both voluntary and statutorily authorized RRAs.  It also is important to note that RRAs do not function as or replace inspections (except those related to FSVPs). RRAs also would not be conducted during, or as a part of, an FDA inspection, but they could precede, prompt, or be a follow-up to an inspection.

RRA Uses. The use of RRAs will be determined through a public health risk-based approach. Some of the specific reasons RRAs may be undertaken can be gleaned from the agency’s discussion of what was learned from the RRAs of the last two years. That is: “We’ve identified unreported adverse events, gathered information to add products that appear to be violative to import alerts, evaluated the status of companies correcting issues from a previous inspection and helped the agency make regulatory decisions for product premarket submissions.” The RRAs also proved effective in getting essential information to regulators, with FDA then intervening when needed, and using agency resources more efficiently.

FDA stated that it may use RRAs:

1. When it is unable to deploy in-person staff due to travel restrictions.
2. To efficiently assess establishments identified in product applications when these establishments have a prior history of compliance.
3. To review information such as livestreams and records provided by a company without going on-site, to make better use of limited agency resources and give industry more scheduling flexibility. 
4. To support regulatory decisions and oversight activities.

Based on uses during the pandemic, the RRAs may also be used to:

1. Assist FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers.
2. Gaining compliance insight when it is not practicable to inspect.
3. Provide information about deficient practices, which could lead to regulatory actions, onsite inspections, and future inspection planning.
4. Assist in determining compliance with veterinary feed directive regulations, assessing foreign manufacturing process records, adding foreign firms to import alerts, and issuing of warning letters.

Whether having conducted a voluntary or mandatory RRA, upon completion, FDA may meet with the establishment’s management, present a written list of RRA observations, if any, and discuss the observations (defined as conditions and/or practices observed that indicate a potential regulatory violation). 

Which leads to some “howevers” of the guidance, e.g.,

1. FDA will not issue a Form FDA 483 for an RRA, however FDA may conduct a follow-up inspection or take other appropriate actions, including an enforcement action, when significant issues are discovered.
2. FDA written list of observations will not be considered a final agency action or decision, however, evidence collected during an RRA may be used in support of any such action or decision; and FDA may combine RRA information with observations from a subsequent inspection.
3. A facility can decline a FDA’s request for a voluntary RRA, however FDA may then consider other actions “to exercise our oversight responsibilities of that establishment, such as an inspection.”

While an RRA can benefit the facility at which it is conducted – identifying issues for which corrective action can be made before an inspection and reducing costs by decreasing the time needed for the inspection and records review – a notification of an RRA should not be taken lightly. Not only does it inform FDA of issues you may have, “any written list of observations may be subject to a request under the Freedom of Information Act at the time the disclosure to the establishment is first made.”

Keeping your facility “inspection ready” takes on new importance with the RRA extension, as the efficiency gained and ability to “assess” more facilities in a shorter time makes your facility that much more susceptible to FDA eyes.