S47 Stories from the Trenches:  FDA Inspection after Food Safety Modernization Act (FSMA) Implementation

Tuesday, July 11, 2017: 1:30 PM-5:00 PM
Ballroom C (Tampa Convention Center)
Sponsored By:
Primary Contact: Wendy White
Organizers: Akhila Vasan and Wendy White
Convenors: Akhila Vasan and Wendy White
There is no doubt that the Food Safety Modernization Act is the most sweeping piece of food legislation for American manufacturers in over 70 years. The FDA has also paired updated regulations with an overhaul to their inspection program.  As a result, the entire industry is on pins and needles to see how these changes will directly affect them, when their inspector comes to visit. Though the Preventive Controls for Human Food Rule’s compliance deadline for large establishments, Sept. 19, 2016, will have long past by the time IAFP members storm the sunny city of Tampa for the Annual Meeting, the FDA will have had time to inspect a very small percentage of U.S. facilities.  Most IAFP members will not have had exposure to the new FSMA inspection process.

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.

Presentations

1:30 PM
1:30 PM
FSMA Inspection: An Inspector's Perspective
Lillian Hsu, U.S. Food and Drug Administration-CFSAN
3:00 PM
Break – Refreshments Available in the Exhibit Hall
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