Ensure public health and a seamless supply chain with FDA CertPRO’s expert regulatory services, cutting-edge compliance software, and industry-leading training solutions—tailored for the food and beverage industry
Register with FDA
Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations is crucial for businesses in the food and beverage industry. At Consult CertPRO, we specialize in providing comprehensive regulatory services, innovative software solutions, and interactive online training to help you protect public health and strengthen your supply chain.
Leveraging decades of combined industry experience, our team assists domestic and international food and beverage companies in navigating complex regulatory landscapes. Our services include:
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We offer U.S. Agent services encompassing facility registration and renewal assistance, DUNS number acquisition, 24/7 representation for FDA communications, and mock FDA inspections at reduced fees. Clients also gain access to MyFDA, our proprietary online portal for managing FDA registration and compliance data.
To meet alcohol importers' tax benefit assignment requests, we assist with Alcohol and Tobacco Tax and Trade Bureau (TTB) registration and provide guidance on operating their new online system, ensuring compliance with updated TTB requirements.
For businesses planning to export food products to China, we support the General Administration of Customs China (GACC) registration process, including product category application submission, FDA registration assistance if applicable, and export listing updates.
Our qualified food safety specialists collaborate with you to develop comprehensive plans such as Food Safety and HACCP plans, Food Defense plans, and FSVP plans. Additional services include acting as FSVP Agent, implementing FSVP, and conducting mock FDA inspections for both food facilities and U.S. importers.
We guide you through compliance with FDA regulations for Low Acid and Acidified Canned Foods, assisting with necessary registrations, documentation, and process filings, including FCE registration and Submission Identifier (SID) filings.
To prevent costly detentions due to improper labeling, we provide in-depth reviews, detailed reports, and one-on-one expert assistance, ensuring your products meet FDA's extensive labeling regulations.
We streamline the process of submitting advance notice for shipments to the FDA, allowing you to file multiple Prior Notices accurately and on time through our Prior Notice Express service.
If your products face Detention without Physical Examination (DWPE) due to an Import Alert, our team helps develop and document corrective action plans and submits petitions for removal to facilitate smooth border crossings.
We assist in resolving refusals at ports of entry by identifying potential solutions to the FDA's charges, including submitting Testimony of Admissibility or Form 766 reconditioning requests, thereby preventing disruptions to your supply chain and protecting your company's reputation.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register their facilities with the FDA, unless exempt under the Code of Federal Regulations. This requirement applies to domestic facilities regardless of whether their goods enter interstate commerce.
Certain facilities are exempt from FDA registration, including farms, retail food establishments, restaurants, and non-profit food establishments that prepare or serve food directly to consumers. Additionally, facilities that process food solely for personal consumption or that are regulated exclusively by the U.S. Department of Agriculture are exempt.
At Consult CertPRO, we are committed to guiding you through the complexities of FDA regulations, ensuring your food and beverage products comply with all necessary requirements for successful market entry and distribution.