During the COVID-19 pandemic, FDA began utilizing remote techniques as part of its regulatory oversight. Due to the pandemic, FDA had a substantial backlog in inspections, and remote alternatives or supplemental activities were developed to help alleviate the backlog. One of the remote techniques adopted were Remote Regulatory Assessments (RRAs). RRAs can include remote evaluations of risk or remote records reviews. FDA has indicated that the agency will continue to utilize RRAs when possible, even beyond the pandemic, as part of its move to modernize inspections. The agency issued a draft guidance on RRAs in July of 2022, which details FDA’s approach to RRAs.
For food companies, FDA has predominately used RRAs to conduct remote Foreign Supplier Verification Program (FSVP) inspections. The regulations implementing FSVP requirements expressly include that FDA can require FSVP records to be submitted electronically to the agency for review, and an on-site inspection is not required. 21 CFR 1.510(b)(3). When FDA requests an RRA to conduct a review of FSVP records, the agency considers participation by the company to be mandatory under this regulation.
However, FDA can also use RRAs to assess the overall risk of a company or review corrective actions implemented by a company in response to a recommendation or request by the agency. Participation by a company in these requests for an RRA by FDA is, however, voluntary. If a company declines to participate in a voluntary RRA, FDA has indicated that other methods for evaluating the company would be considered. FDA does not consider these voluntary RRAs to be inspections, and are, instead, additional tools that can be used to determine compliance. The agency has indicated that, for example, RRAs can be used to prepare for an upcoming inspection or to conduct follow-up after a consumer complaint. Voluntary RRAs will not be conducted simultaneously with on-site inspections but may be used to either prepare for an on-site inspection or to conduct follow-ups following an on-site inspection. By conducting an RRA before or after an on-site inspection, FDA believes that the on-site inspection will be more targeted and efficient, better utilizing FDA’s time on-site and alleviating the resource burden on companies associated with having FDA on-site.
What to Expect:
If your company is selected for a RRA, either voluntary or mandatory, FDA will contact the company’s point of contact through email or phone call. The company’s point of contact will be determined through the company’s FDA registration. Then, if the RRA is voluntary, FDA will request a written confirmation from the company that indicates the company is willing to participate in the RRA. If a company declines to participate in a voluntary RRA, this is not considered a refusal of inspection.
For mandatory RRAs relating to FSVP records, FDA will issue an FDA 482d, a Request for FSVP Records. This form will detail the records FDA is requesting, and those records can then be provided electronically by the company through the FSVP Importer Portal. A refusal to participate in a FSVP RRA is considered a refusal of inspection and may result in enforcement action taken against the company or products currently being imported by the company.
For voluntary RRAs, FDA will then coordinate with the company’s contact person to determine how the RRA will occur and what information will be requested from the company. These conversations will be used to set the process for conducing the RRA as well as the expectations for the RRA. This may occur during an opening meeting or though other communications between the agency and company. FDA can request meetings or interviews with employees, or the agency may request records to review. FDA could additionally request video, including pre-recorded video or a livestream, or photos of the facility.
Data protection and security must be considered when participating in an RRA. FDA has indicated that a company’s preferred video or audio system can be used for RRAs, and FDA has provided secure options for transmission of records. In addition, for voluntary RRAs, FDA has utilized screensharing technologies to conduct records review when a company does not want to provide copies of the records to the agency. Screensharing additionally provides an opportunity for the company to provide additional context or narrative related to the records and documents being shared. Additionally, if livestream video, prerecorded video, or photographs are provided to the agency as part of an RRA, image quality must be considered, including any possible misperceptions due to the image quality. Also, risks of communicating confidential business information and trade secrets must be evaluated before participating in a voluntary RRA; when video or photographs are provided, food defense and the risk of intentional adulteration should also be considered.
FDA will work with the company to set a timeframe for providing requested information and records. For mandatory RRAs addressing FSVP records, requested records must be provided within a “reasonable” time. 21 CFR 1.510(b)(1).
Following an RRA, FDA may set a close-out meeting with the company’s contact person. In this meeting, FDA may present a list of observations from the RRA and may discuss those observations to ensure the company fully understands the observations noted. For mandatory RRAs regarding FSVP records, FDA may issue a Form FDA 483a, which is used to issue observations to an importer indicating that the importer is not in compliance with FSVP requirements. Voluntary RRAs will not result in the issuance of a Form FDA 483, though FDA may utilize the observations noted during an RRA when conducting an on-site inspection; if the noted observations remain during the on-site inspection, a Form 483 may be issued. FDA will document the RRA in a narrative report, along with the list of observations; the narrative portion of this report will be provided to the company following closing out the RRA.
FDA has indicated that the company should participate in this close-out meeting to provide responses to the observations, and additionally recommends that the company respond in writing to the observations, similar to the practice of responding to Form 483s.
Though RRAs provide an excellent opportunity to develop relationships with FDA, and for FDA to evaluate companies in an efficient manner, possible risks associated with participation in a voluntary RRA should be considered before agreeing to participate. In addition, if selected for a mandatory RRA to review FSVP records, companies must ensure that they comply with providing the records requested in a timely manner to ensure compliance with FDA's authority.
Liz Presnell is a food industry consultant and lawyer, and has worked in the food industry for nearly a decade. She can be reached at presnell@foodindustrycounsel.com.