FDA has outlined an inspection system that targets riskier facilities, utilizes experts for inspector and plant support, and promises a quicker turn-around for final inspection reports. These will be welcome changes and most of the industry is very eager to learn how well the new system operates. Is the sky really falling or will these changes usher-in an unprecedented period of transparency, cooperation, and streamline the FDA inspection process? We are very interested to better understand this process from first-hand accounts of those involved in the first round of FSMA inspections.
This session will directly address: (1) An FDA inspector’s perspective on how the first round of FSMA inspections have gone. What are the big gaps that they’ve seen, and how can the industry be better prepared? (2) Challenges from the industry’s perspective, a first-hand account of a site representative that has facilitated a FSMA inspection. (3) A broader view of industry feed-back from these first few months of FSMA implementation from Grocery Manufacturers Association's (GMA) membership and the GMA Science and Education Foundation.