We have reported previously that US FDA stopped sending their personnel to inspect foreign manufacturers in China due to widespread outbreak of COVID-19. As reported today, the FDA is now postponing most foreign inspections through April, effective immediately. However, inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For US-based
The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19). These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA is particularly concerned that products that claim to cure, treat or prevent
This week the FDA has issued a final rule banning Electrical Stimulation Devices (ESD’s) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of injury or illness that cannot be corrected or eliminated through new or updated device labeling. These devices have been associated with an extensive list of serious
This week the commissioner of the FDA released a new update regarding the effects and response of the FDA in relation to the Coronavirus. The FDA has emphasized that they are taking a multi-faceted approach to this public health emergency. This approach includes facilitating efforts to diagnose, treat, and prevent the disease; surveilling the medical
This past week, Costco Wholesale Corporation became the first approved participant in the FSMA Voluntary Qualified Importer Program (VQIP). This program is a voluntary, fee-based program that allows importers to receive expedited review and importation of human and animal foods into the United States under the FSMA. Costco has shown management of safety and security
FDA Reclassification Updates Earlier this week, the FDA issued a final order which reclassified several families of medical devices. These devices include certain radiological medical image analyzer such as Computer-Assisted Detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices. These devices have been reclassified from
FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs The FDA issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple cGMP regulation violations at
FDA Will Continue Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA. The FDA will be continuing its enforcement discretion policy for compliance with certain FDA Food Safety Modernization Act (FSMA) supply-chain program requirements applicable to receiving facilities that are co-manufacturers. “Co-manufacturing” is when one party (the brand owner) arranges for a second party (the
FDA Announces Cooperative Agreement to Implement Produce Safety Rule The U.S. Food and Drug Administration (FDA) announced a cooperative agreement with the National Association of State Departments of Agriculture (NASDA) that was established to help carry out the produce safety rule as part of the FDA’s ongoing efforts to implement the FDA Food Safety Modernization
Federal judge enters consent against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx for drug, device, and dietary supplement violations. A federal judge in Tennessee ordered a consent decree of permanent injunctions against two Tennessee-based companies, Basic Reset and Biogenyx. The permanent injunction prohibits the two companies and their owners from distributing
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