Many produce importers overlook one of the most frequently cited FSVP requirements: documenting supplier evaluations that demonstrate compliance with FDA’s Produce Safety Rule. Learn what FDA expects and how to strengthen your FSVP before an inspection.
USDA Food Safety and Inspection Service (FSIS) labels play a critical role in product compliance and market access. This article explores the FSIS label approval process, including generic, sketch, and temporary approvals, while highlighting common compliance challenges and the recordkeeping requirements establishments must maintain to support approved labeling claims.
FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.
Accessing the U.S. market requires more than product compliance. Learn how the FSIS equivalence process works and where foreign inspection systems often fall short.
Food recalls are increasing despite stronger regulations and expanded food safety systems. In this Issue of the Month, EAS consultant Amandeep Dhillon examines the systemic causes behind this trend and what companies must do differently to reduce risk.