U.S.A RRA FDA Draft Guidance:
In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation of Remote Regulatory Assessments (RRAs). Questions and answers outlined the regulatory oversight during and after the COVID-19 pandemic.
The draft, “Conducting Remote Regulatory Assessments: Questions and Answers,” outlines the FDA’s use of RRAs to continue regulatory oversight in the short and long term. The draft guidance states that RRAs, which allowed FDA to assess an establishment’s compliance while there were travel restrictions, have been proven. The FDA has determined that continued use of RRAs will benefit the post-pandemic world and across all FDA-regulated industries.
Remote Regulatory Assessments:
RRAs are optional in some situations, while they are required in others. For American food importers participating in the Foreign Supplier Verification Program (FSVP), RRAs are required. Establishments must make sure that the necessary FSVP documents are kept properly, in English, and easily accessible to FDA when it is implementing RRAs to evaluate their compliance because record-keeping is a crucial component of FSVP compliance.
Businesses that only import products are not regarded as facilities unless they also manufacture, process, pack, or store food. However, rather than FSVP for US importers, FDA would instead examine for compliance with the Supply Chain Program under 117 (like FSVP for food facilities).
FDA FSVP Record Reviews (FSVP Rule):
A range of activities for which the FDA may use multiple terminologies, but that are all deemed to be forms of RRAs, including remote interactive evaluations and remote record reviews, according to the FDA.
According to the FSVP rule, each imported product from each supplier must be supported by paperwork that shows FDA food safety compliance.
The FSVP needs to be updated at least every three years, or if important supplier/product information changes, such as the facility’s address, or when a new ingredient or procedure is added that has an impact on the hazard analysis or other FSVP evaluations.
FDA Timeframes for Establishment FSVP Records:
FDA assesses each situation individually before determining the required timeframe for an institution to submit records for a required RRA. However, importers are required by the Federal Food, Drug, and Cosmetics (FD&C) Act to deliver FSVP records “promptly to the FDA upon request.” The records must be supplied electronically or in another way that enables fast delivery when the FDA makes a written request for them.
The FDA Compliance Officer will ask for the records to be submitted using the FSVP Importer Portal for FSVP Records Submission during RRAs. The portal will ask importers to register for an account and upload the required FSVP information.
The documents need to be arranged and identified correctly. They might also be emailed in at other times. FDA is a legally recognized organization and will request physical records at the importer’s business headquarters.
What are the FSVP Non-Compliance penalties?
FDA may refuse a U.S. importer’s food imports at the U.S. port of entry (21 CFR 1.514(a)), and the importer may be in violation of section 805 of the FD&C Act if they don’t answer to the FDA’s request for FSVP reports. Among the behaviors that FDA may deem as declining to engage in a mandatory RRA are actions like withdrawing participation and refusing to give FDA access to records.
Additionally, FDA will issue a Form 483, summarising the inspectional observations, if violations are discovered during an FSVP inspection. FDA will publicly issue a Warning Letter, which can progress to issuing a public Import Alert 99-41 if an importer does not respond and take corrective steps within 15 days.
Once an Import Alert is issued, the FDA will detain an importer’s violative food shipments without the need for physical examination. This effectively can shut down an importer’s business. Therefore, it is critical that your FSVP certification is done properly to avoid non-compliance penalties.
How Quality Smart Solutions can help
Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published.