In recent months, it appears more companies are having difficulties meeting the requirements of FDA Form 483, List of Observations, response. The inspection situation is very stressful and if it ends with the dreaded “483”, it can be positively overwhelming. However, when the initial reaction is over, it’s time to rally the staff and prepare… Read More
Recent Issue of the Month Article
Recent Announcements
Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations
As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures… Read More
Foreign Supplier Verification Program – What Does it Mean for You?
Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted? En Espanol Si usted exporta alimentos, ingredientes, empaques, suplementos o aditivos alimenticios hacia los Estados Unidos, su agente aduanal en los Estados Unidos, importador y clientes le pedirán proporcionar documentación para verificar que su empresa cumple con la Ley de… Read More
EAS Independent Advisor for Food Law and Regulation, Steve Armstrong, Winner of 2018 Service to FDLI Award
EAS is pleased to announce that Independent Advisor for Food Law and Regulation, Steve Armstrong, is the winner of the 2018 Food Drug Law Institute’s Service to FDLI Award. Mr. Armstrong, the former Chief Law Council for the Campbell Soup Company, joined EAS as an Independent Advisor in 2016 and has been instrumental in assisting… Read More
Recent White Papers
An Overview of Drug Master Files
DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and storing of one or more APIs and/or human drugs. DMFs are at the discretion of the DMF holder and… Read More