On March 17, 2020, the U.S. Food and Drug Administration (“FDA”) issued a Temporary Policy regarding preventive controls and food supplier verification audit requirements during the COVID-19 public health emergency. This guidance explains the current intent of FDA to not enforce onsite audit requirements in certain circumstances related to the impact of COVID-19. Such onsite audit requirements can be found in three important food regulations:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117);
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507); and
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR Part 1 Subpart L).
The Agency has stated that this temporary guidance will become effective immediately, without comment from the public, due to the exigent circumstances surrounding this ongoing public health threat.
Continue Reading FDA Issues Temporary Guidance on Food Supplier Verification Audit Requirements