Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements

The purpose of this guidance is to state the current intent of the Food and Drug Administration (FDA, we, or the Agency), in certain circumstances related to the impact of the coronavirus outbreak (COVID-19), not to enforce requirements in three foods regulations to conduct onsite audits of food suppliers if other supplier verification methods are used instead.

The three regulations are Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117) (“part 117”) [1], Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507) (“part 507”) [2], and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR part 1 subpart L) (“FSVP regulation”) [3].

We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). This guidance is immediately effective because FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)). The agency has made this determination because there are public health reasons for the immediate implementation of the guidance document; in particular, the guidance addresses exigent circumstances related to an ongoing public health threat.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

The full guidance here: https://www.fda.gov/media/136142/download

Source: www.fda.gov