Which Facility Must Register With The FDA?
Friday, 27 March 2026
by Dr Faour Klingbeil
I often get questions on FDA registration from both startups and established companies. For example, Does our third-party warehouse need to register with FDA? If it holds food for US consumption, most likely, yes.First, what does the law state? FSMA requires that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with the FDA. So, a third-party warehouse used exclusively for storing your finished products is still a food holding facility. That brings it within FDA’s registration requirement, regardless of whether it handles products from one company or many. Almost all warehouses that handle food meet at least the “hold” threshold under FSMA, which means they are: 🔸Subject to FDA registration 🔸Expected to have applicable food safety controls in place This applies to domestic and foreign facilities alike. If the facility packs or holds food after the last foreign manufacturer or processor, the foreign packer or holder must also register. In multi-facility chains, more than one site may need registration. Exemptions apply to retail food establishments (restaurants/groceries) and farms holding their own produce are typically exempt. Pure carriers (trucks in transit) are generally not considered facilities, but the warehouses they transfer to are. ❗️NOTE: FDA registration is free See below details on which facility types must register, including scenarios involving multiple foreign facilities. If you have questions about what FDA registration means for your facility, which regulations apply to your operation, or how to design compliant food labels and build a compliant HACCP and Food Safety Plan for the US and EU market, DFK Safe Food Environment provides regulatory consulting, FSPCA training, and FSMA compliance support for domestic and international food businesses.
- Published in FDA Compliance, FSMA
DFK Supports SMEs and Stakeholders Through the USAID TRADE Project on Export Enhancement Program
Tuesday, 26 March 2024
by Dr Faour Klingbeil
As part of the Export Enhancement Program under the USAID TRADE project, in collaboration with the Food Export Council (FEC), DFK has been dedicated to supporting SMEs and key stakeholders by enhancing their knowledge and capabilities. This initiative, which began in September 2022, continued through multiple training sessions held on: The objective of these sessions was to train and build the capacity of industry delegates and trainers on the FDA requirements under the FSMA preventive controls rule key and topics essential for international trade compliance and food safety, including: This effort continued through 2024 with the development of Trainer of Trainers (ToT) guidance documents, including: Through this project, DFK is empowering SMEs with the critical knowledge and skills needed to meet international standards, fostering safer food products and enhancing export capabilities.
DFK Empowers FEC Members for Global Food Export Success – A USAID Trade Reform & Development Projecy in Egypt (TRADE)
Tuesday, 26 September 2023
by Dr Faour Klingbeil
DFK has been entrusted with the development and delivery of an extensive training program as part of the three-day Export Enhancement Program, held by USAID TRADE, in collaboration with the Food Export Council (FEC), from 24-26 July, 2023 at FEC premises. With a remarkable turnout of over 60 participants, the workshop delved into vital topics, including EU and US food labeling requirements and allergen control programs. Its overarching goal was to fortify the capabilities of FEC members, enabling them to not only meet rigorous EU and US food safety regulations but also to thrive in expanding their presence in export markets. The upcoming training session scheduled for the end of November 2023 will focus on the development of a Food Safety Culture plan. Stay tuned for further updates on our journey to elevate food safety standards and empower our partners in the industry.
DFK Continues Its Collaboration with the Food Export Council, Delivering Guidance on FDA FSMA and Traceability RequirementsJuly 2023 – Cairo, Egypt
Sunday, 23 July 2023
by Dr Faour Klingbeil
For the second consecutive year, DFK has strengthened its collaboration with the Food Export Council (FEC) to support Egyptian food manufacturers and exporters in meeting international regulatory requirements. As part of this ongoing partnership, Dr. Dima Faour-Klingbeil delivered a webinar in July focused on the U.S. Food Safety Modernization Act (FSMA) and the FDA’s Food Traceability Rule. The webinar organized and hosted by the FEC provided exporters with essential guidance for accessing and maintaining compliance in the U.S. food market. Dr. Faour-Klingbeil outlined the transformative nature of FSMA, the most comprehensive reform of U.S. food safety law in decades, which shifts the regulatory system from reacting to food safety incidents to preventing them. During the session, she explained FSMA’s core principles, including preventive controls, inspection and compliance mechanisms, import oversight, and the FDA’s authority to act swiftly on products suspected of contamination. She highlighted key rules that foreign suppliers must understand and especially the Foreign Supplier Verification Program (FSVP), which requires U.S. importers to verify that their foreign suppliers meet U.S. standards. A major focus of the webinar was the FDA’s Food Traceability Rule, which expands traceability requirements across the global food supply chain. Dr. Faour-Klingbeil detailed the obligations for documenting Key Data Elements (KDEs) and Critical Tracking Events (CTEs), underscoring the rule’s significance for high-risk foods and the need for robust record-keeping systems to enhance recall efficiency and supply-chain transparency. Dr. Faour-Klingbeil urged Egyptian exporters to proactively strengthen their compliance systems to avoid border rejections and improve their competitiveness in the U.S. FEC emphasized that these training initiatives form part of a broader strategy to expand export capabilities and support companies participating in major global trade events. For more information, Watch the webinar in this link:
PCQI WORKSHOP – USAID Trade Reform & Development in Egypt (TRADE) 2023
Friday, 24 March 2023
by Dr Faour Klingbeil
For the second year, and as part of the integrated capacity enhancement initiative of the USAID TRADE project to strengthen the Egyptian Food Export Council (FEC) and their members’ capacity to access the US market, Dr Faour-Klingbeil delivered the official course “Preventive Controls Qualified Individual (PCQI)” for 12 SMEs at the FEC premises from 07.- 09.03.2023. The course aimed to support Egyptian SMEs in the food sector better understand how to develop a Food Safety Plan and meet the FDA food safety requirements to improve regulatory compliance and enhance food exports.




