FDA-regulated products remain subject to regulatory risk across the supply chain. FDA’s September 23 action against Gold Star Distribution is a reminder that warehousing and distribution are part of the regulated product supply chain. Tips for managing 3PL, warehousing, distribution, supplier, and compliance risks for food, drug, medical devices, and cosmetics across state and federal requirements.
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U.S. Food and Drug Administration (FDA) issued a Warning Letter to U.S. food importer, B&I Overseas Trading Inc., for failing to implement supplier verification protocols, as required under the “Foreign Supplier Verification Program” (FSVP), to assure that fish imported by the company into the U.S. was produced in accordance with U.S. food safety regulations. In the FDA
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In light of the recently finalized Deeming Rule, the FDA has been conducting periodic compliance check inspections to determine tobacco retail establishment’s compliance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and found several violations of the federal tobacco laws and regulations while conducting inspections. As a result, the FDA has
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Since 2015, an increasing number of cosmetic companies have come under the harsh scrutiny of the US Food and Drug Administration (FDA) for reasons ranging from “misbranding” due to drug like claims to “adulteration” by contamination. The FDA’s increased focus on cosmetic companies and cosmetic products is seen in the recent uptick in warning letters,
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On February 29, 2016, the FDA published a guidance entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy.” The guidance is effective immediately (starting on Tuesday, March 1) and states that the Agency will not take action against first responders failing to obtain product tracing information, as required under
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Feb. 4, 2016 — The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced the finalization of new federal poultry standards to reduce Salmonella and Campylobacter in chicken and turkey products. FSIS estimates that implementation of these new poultry standards will lead to an average of 50,000 prevented illnesses annually. As part of this
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The Center for Medicaid and Medicare Services’ (CMS) Pioneer Accountable Care Organization (ACO) program successfully saved Medicare nearly $400 million in spending over two years, clearing the way for CMS begin expanding the program nationwide. A CMS study released May 4, 2015 on the JAMA website, revealed that expenditures for Medicare beneficiaries receiving care through
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On April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss, energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat. These warning letters come over one year
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Today, the U.S. Department of Agriculture (USDA) Animal Plant Health Inspection Services (APHIS) announced the potential expansion of fresh produce imports from Peru including papayas, oversized mangoes, peppers, and citrus, stating in its press release: [t]he U.S. Department of Agriculture (USDA)and the Peruvian Ministry of Agriculture (MOA) met in Washington, D.C., to recognize recent market
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Today the FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). When finalized, this guidance will provide information on: FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices The special considerations that apply
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