FDA Solutions Group, LLC, a Miami-based regulatory compliance company, has opened its doors just in time to assist the thousands of food industry companies affected by the new re-registration requirements of the Food Safety Modernization Act (FSMA).
Under FSMA Section 102, all domestic and foreign facilities that manufacture, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the Food & Drug Administration (FDA) before the end of 2012. FSMA Section102 changes the registration requirement for food facilities originally established in 2002 under the Bioterrorism Act. In addition to requiring all food facilities to re-register in 2012, FSMA requires re-registration every two years thereafter.
FDA Solutions Group is hardly a newcomer when it comes to the process of assisting new and existing food manufacturers and food importers meet FDA registration requirements. Not only does the company have a robust and efficient registration system already in place, the company's principals head up the FDA practice of Sandler, Travis & Rosenberg, PA, a customs, international trade and business law firm that has been a leader in helping clients comply with FDA requirements for 35 years.
FDA Solutions Group operates independently and offers client companies the benefit of its principals’ years of experience, knowledge and expertise in FDA regulatory matters.
FDA Solutions Group doesn't charge law firm prices for its services because it is not a law firm. Rather, the company's fees are very competitive, in keeping with its mission of providing cost-effective registration and agency services to companies affected by the new FSMA registration rules.
"We formed FDA Solutions Group ,LLC to offer a streamlined, efficient and cost-effective approach to meeting the FDA’s new re-registration and compliance requirements, imposed by the FSMA," says company Managing Director Ann Marie Gaitan. "This company was formed by professionals who understand the needs of the food manufacturing, packaging and importing community. We bring knowledge, experience and a dedication to client services that are unmatched in the industry."
Along with registration services, FDA Solutions Group also acts as U.S. Agent for its clients, a designation that now has become a risky proposition for providers who accepted U.S. Agent status in the past.
“Before the new law, it wasn’t unusual for customs brokers and freight forwarders to act as U.S. Agents,” explains Edgar Asebey, the company’s Executive Director. “But that is definitely changing. Where before there was little if any risk involved in becoming a designated U.S. Agent, the FSMA imposes new burdens and potential liabilities on entities serving in that capacity for foreign food facilities. That has made many who have historically accepted agent status rethink whether they want to continue offering that service.”
Asebey points out that under FSMA Section 107, the FDA can begin charging a $289 per hour fee for foreign facility re-inspections. “FDA fees for reinspection could reach several thousand dollars for just one facility,” he says. “And it is the U.S. Agent who will be held responsible for seeing that these fees are paid.”
Asebey says that customs brokers and freight forwarders, wary of taking on this added responsibility, are becoming the primary source of referral for FDA Solutions Group’s services.
“We are happy to work with brokers and forwarders to serve their clients in these important registration and agency matters,” Asebey says. “We provide a service that really is a one-stop shop for food industry companies and the brokers and forwarders that serve them.”
Information about FDA Solutions Group's FSMA registration services and its other offerings can be found at www.fdasolutionsgroup.com or by calling (305) 702-3161.