International FDA consulting firm, FDAImports.com, continues to expand its team of regulatory advisors and staff, adding two new members to its growing Maryland headquarters.

Thomas Knott, Senior Regulatory Advisor
Mr. Knott brings over 30 years of experience and leadership with the U.S. Food and Drug Administration to the firm.  He holds a B.A. in Chemistry from Johns Hopkins University and has published numerous protocols and draft guidance documents for FDA.  At FDAImports.com, Mr. Knott brings his considerable expertise in medical device compliance to bear, helping companies with complex 510(k) applications.  … READ MORE

Share

This post was contributed by FDAImports.com Senior Regulatory Advisor, Tom Knott

FDAImports.com recently saved a U.S importer of medical components the substantial cost of unnecessary laboratory testing for one of their products. When the U.S. Food and Drug Administration (FDA) found Quality System issues with the importer’s foreign manufacturer, the Agency sent that foreign facility a Warning Letter placing all of their products on Import Alert 89-04, “Detention of Devices from Firms that Have not Met Device GMPs.” Immediately FDA began to automatically detain the importer’s … READ MORE

Share

Customs brokers and importers who act as U.S. Agents on behalf of their foreign food manufacturing suppliers now face a new financial risk under the Food Safety Modernization Act.  Before FSMA there was no such thing as an inspection fee for a foreign facility that might become subject to a reinspection.  Now, FDA reinspections will incur a $289/hour (foreign reinspection fee) charge from FDA. FDA expects to use these charges to generate $25 million per year in … READ MORE

Share

FDAImports.com Founder and CEO, Benjamin England, recently spoke at the Food and Drug Law Institute’s Annual Conference on the Food Safety Modernization Act and imports.  During the presentation, “How FSMA Changed the Game on Imports,” Mr. England discussed, along with leading FDA lawyers and industry and FDA officials, elements related to FSMA affecting imported foods and international trade, including the Foreign Supplier Verification Program (FSVP), the Voluntary Qualified Importer Program (VQIP), various challenges to the international supply … READ MORE

Share