Jan 29, 2024 | Drug and Device Corner, Drugs, Medical Devices, Uncategorized
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. Although the FDA...
Sep 27, 2023 | FDA and USDA Regulatory Update, Uncategorized
On September 26, 2023, US FDA issued an updated Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This new guidance material includes a new chapter specific to allergens. Key take-aways include: Establish and Implement a...
Jul 17, 2023 | Uncategorized
Mar 30, 2023 | Uncategorized
USDA Consulting On-Demand Webinar Hear from the Experts: Meeting USDA Federal Food Regulatory Requirements Learn how to expand your operation without sacrificing safety. How are you preparing for the long-term growth of your business? Whether you’ve recently...
Feb 23, 2023 | Uncategorized
May 24, 2022 | Uncategorized, Who’s Who at EAS
Joe Mitchell has extensive experience in Pharmaceutical, Dietary Supplement and Food Quality Management Systems. This thorough knowledge results in practical implementation of applicable cGMP regulations and compliance with federal requirements. Joe has served in...