Registrar Corp Guides Companies through U.S. FDA Regulations

(The process of exporting FDA-regulated products to the U.S. can be difficult.  Registrar Corp, an FDA consulting firm, helps companies comply with FDA regulations.)

With South Africa’s fast growing economy, it’s no surprise that more South African companies are deciding to export to the U.S.  Since 2003, imports from South Africa have increased 83%.  Exporting products to the U.S. can be greatly beneficial, but getting your products across the border can be tricky. In 2013 the U.S. Food and Drug Administration (FDA) refused U.S. entry for 96 exports from South Africa for reasons including facilities being unregistered, labels missing required information, products using prohibited ingredients, missing forms, and more. These are common mistakes that Registrar Corp, a U.S. FDA compliance firm, can help you with.

Registrar Corp has 17 offices around the world, including a representative in South Africa offering services to all African countries.  Registrar Corp’s South Africa office is currently assisting over a hundred African companies with FDA regulations.  Office Manager Chandre Conradie, and Registrar Corp Vice President David Lennarz, anticipate growth in exports will remain strong.  According to Lennarz, "the African continent holds enormous potential, and we are at the tip of the iceberg when it comes to U.S. importers realizing they need to lay their sights on Africa and begin to develop suppliers from the continent.” 

The majority of African companies registered with the U.S. FDA are food facilities. The FDA Food Safety Modernization Act (FSMA) expands the responsibilities of food facilities and their U.S. importers.   Under FSMA, food facilities registered with FDA are required to renew their registrations between October 1^st and December 31^st of each even-numbered year. With the 2014 FDA registration renewal period approaching, food facilities that plan to continue exporting products into the U.S. need to begin preparation. Failing to properly renew a facility’s registration can lead to detention of products or even cancellation of a facility registration.

FSMA also gives FDA authority to administer fees for reinspections of food facilities.  If an initial FDA inspection reveals certain food safety issues, FDA will charge for the number of direct hours spent on the reinspection, including preparation and traveling to and from the facility.  Beginning October 1, 2014, the fee for reinspections of foreign facilities is $305 U.S. dollars an hour.

Along with registration and product compliance, food, drug, and medical device companies located outside of the U.S. are required to list a U.S. Agent to facilitate communication between FDA and the foreign company.  FDA will contact the U.S Agent with questions about specific shipments and to schedule inspections.  Since the U.S. Agent responds to FDA on behalf of a foreign company, it’s important to designate someone with expertise in FDA regulations.  Registrar Corp acts as U.S. agent for over 12,000 foreign food, medical device, and drug companies.   As an additional benefit for food facilities, if a firm receives a notice of FDA inspection, Registrar Corp will send a food safety expert trained in FDA inspections to the foreign facility to help prepare. This preparation service is included at no extra charge other than travel and lodging expenses.

Registrar Corp’s Regulatory Specialists can help food, drug, medical device and cosmetic companies properly register with FDA, review product labels for FDA compliance, act as a U.S. agent, and more.  For questions about U.S. FDA regulations or to learn more about how Registrar Corp can help your business, contact Registrar Corp’s U.S. office at 1-757-224-0177 or the South Africa office at +(27)-21-979-5383. Receive online Live Help from Regulatory Specialists 24 hours a day at: http://www.registrarcorp.com/livehelp.