Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more
8/27/2019
/ Accreditation ,
Clinical Laboratory Testing ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Foreign Suppliers ,
FSMA ,
Regulatory Oversight ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more
8/16/2019
/ Enforcement Actions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Safety ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Imports ,
Public Health ,
Regulatory Violations ,
Salmonella ,
Supply Chain ,
Verification Requirements ,
Warning Letters
The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more
The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more
The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization...more
U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era...more
The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing,...more
FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more
3/29/2019
/ Agribusiness ,
Biotechnology ,
Cooperative Agreements ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
FSMA ,
GMO ,
Imports ,
Public Health ,
Regulatory Standards ,
Safety Inspections ,
Safety Precautions
The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more
The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more
3/15/2019
/ Agribusiness ,
Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Supply ,
FSMA ,
Health & Safety Standard ,
Regulatory Oversight ,
Regulatory Requirements ,
Vulnerability Assessments
This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the...more
The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this...more
11/12/2018
/ Agribusiness ,
Animal Food ,
Baby Products ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Recalls ,
Food Safety ,
FSMA ,
Regulatory Standards ,
Retail Market ,
Safety Precautions
The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA...more
The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more
The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more
The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier...more
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics:
- Guidance on application of the Foreign Supplier...more
3/27/2018
/ Agricultural Sector ,
Farm Animals ,
Farms ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Imports ,
Regulatory Oversight ,
Regulatory Standards ,
Wine & Alcohol
The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation....more