The Investigations Operations Manual is the standard for FDA field investigations. It explains how FDA investigators are taught to act, what to look for, and what to do when they find a noncompliance at a food facility. The latest version, which came out in June 2022, contains an important update on environmental monitoring.
The U.S. Food and Drug Administration (FDA) will hold several instructor-led workshops, both virtually and in-person, on conducting self-assessment and verification audits for the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) throughout 2023.
Officials from the U.S. Food and Drug Administration (FDA) recently held a conversation to explain to stakeholders how the agency handles foodborne illness outbreaks and other adverse food safety events, as well as how FDA plans to improve its processes. FDA also released a supplementary video illustrating its processes.
The U.S. Food and Drug Administration has released a guidance for industry that describes the actions, behaviors, and statements made by a foreign food establishment or foreign government that the agency considers to be a refusal of an FDA inspection.
To help small entities participate in or comply with the Laboratory Accreditation for Analyses of Foods (LAAF) program, the U.S. Food and Drug Administration (FDA) has published the Small Entity Compliance Guide.
Part of Food Safety Magazine’s series with the U.S. Food and Drug Administration (FDA), titled, “Evolution of a New Era: Advancing Strategies for Smarter Food Safety,” this episode of Food Safety Matters discusses the agency’s commodity-specific strategies to prevent foodborne illness outbreaks through FDA's Foodborne Outbreak Response Improvement Plan under the New Era of Smarter Food Safety initiative. We are joined by Stephen Hughes, Prevention Coordinator in the Office of Food Safety at FDA's Center for Food Safety and Applied Nutrition, and Dr. Jennifer McEntire, Chief Food Safety and Regulatory Officer at the International Fresh Produce Association (IFPA).
The U.S. Food and Drug Administration (FDA) will host a series of four webinars on the Infant Formula Transition Plan for Exercise of Enforcement Discretion.
The U.S. Food and Drug Administration (FDA) has launched its Retail Program Standards Reference System, a searchable database of current Voluntary National Retail Food Regulatory Program Standards interpretations.
As part of the Closer to Zero Action Plan, the U.S. Food and Drug Administration has asked the National Academies of Sciences, Engineering, and Medicine to conduct an independent study to assess young children’s exposure to mercury from consuming seafood.
We have been monitoring the relationships between food processors and regulators for a number of years. Our attention to this topic started with the implementation of FSMA to watch the evolution of the FDA's enforcement posture, as well as inspection and sampling procedures related to the new requirements. Now that the FDA has resumed its regular in-person inspections, we asked processors: (1) whether they have had an inspection so far in 2022 and, if so, did FDA collect any samples; (2) now that processors are seeing inspectors again, do they still agree that FDA "educates before it regulates"; and (3) with their experiences from recent and previous inspections, what do processors wish that regulators understood better? This column presents answers from more than 300 food processors in every category on these and related regulatory questions.
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