7 days ago — FDA will hold a drug compounding annual listening session, virtually, from 9-11 a.m. ET on June 17. This listening session is an opportunity for ...
Thursday, May 26, 2022
| Allure Foods LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Las Dos Californias Inc DBA Dulceria los Cuates | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| A.N.N. Imports LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Smart Smoke, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Subhlaxmi Grocers | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Sunny Creek Farm, Inc. | Division of Human and Animal Food Operations East III | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Hope Botanicals, LLC | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | ||||
| Plantacea, LLC dba Kahm | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | ||||
| Haniel Concepts, Inc. DBA Free State Oils, LLC | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | ||||
| JVS Vapor Inc d/b/a Jacks Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Ayuryoga, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drug | ||||
| Allure Foods LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Las Dos Californias Inc DBA Dulceria los Cuates | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Sunny Creek Farm, Inc. | Division of Human and Animal Food Operations East III | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
| A.N.N. Imports LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Smart Smoke, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals
The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest. While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.
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Thursday, May 19, 2022
FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain
Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.
But despite mitigating or preventing hundreds of new drug shortages, disruptions in the U.S. drug supply continue to occur due to drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs or natural disasters.
In 2019, in an effort to address the national drug shortage problem, the federal Drug Shortages Task Force released a report that called for the adoption of risk management plans to proactively assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage. Then in 2020, Congress passed the CARES Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply.
To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.
The draft guidance describes a framework for stakeholders to consider when developing risk management plans that aligns with principles stated in the International Council for Harmonisation guidance for industry, Q9 Quality Risk Management, and identifies risk factors to consider when developing the content of risk management plans. The steps needed to reduce risks of a disruption in drug supply may vary among the different manufacturers in the supply chain for a given drug.
Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply. For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should take every step available to reduce risks and threats to the drug supply chain. Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages.
FDA's “All-in” Approach to Enterprise Transformation
The U.S. Food and Drug Administration's responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every home and used every day across the U.S. As we witnessed during the pandemic, the FDA plays a critical role in enabling access to safe and effective medical products, such as vaccines, therapeutics, and accurate diagnostic testing. The agency also monitors and supports the supply chains for critical components of these products, while continuing to ensure the safety of our food supply, all in an increasingly complex and interconnected environment.
In meeting our public health mission, the FDA must have more effective and efficient business processes, increased capabilities to better use the data that we review, and a more coordinated development of the IT systems designed to support these activities. In the past, the FDA has taken an organization-based approach to process development and IT investments, resulting in siloed solutions and a fragmented data environment. To achieve new efficiencies, the FDA is advancing an agency-wide enterprise approach to business process, data, and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work.
Today we are introducing the Enterprise Modernization Action Plan, which is the next phase of the FDA’s stronger data and technology foundational approach.
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| Evans Farms Feed | Division of Human and Animal Food Operations West III | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
| El Dorado Imports Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Moonlight Vapers | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Vapor Arts LLC d/b/a Main Street Vapor Co. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| The Vapor Gypsy, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Specialty Process Labs LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | ||||
| Lempira Distribution LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Red Shield Reserve Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Colorful Products Corporation | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Triple J Fresh, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| LECS USA Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Fres Co, LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
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