Inspector major observations, enforcement statistics and more. Last week Food Safety Preventive Control Alliance (FSPCA) updated Foreign Supplier Verification Program (FSVP) Lead Instructors on the latest information relative to FSVP compliance and the food industry. As a FSVP lead instructor, I appreciated the summary of FSVP statistics and information presented by Ms. Sharon Mayl, Senior Advisor for Policy with the FDA. Key items Mayl shared included: All inspections to date have been pre-announced. This was due to confirming that the correct individual had been properly identified at time of import. Of the 9 million lines of entry, 6.1 million have entered as “FSV” using a DUNS number. Currently, slightly less than 44,000 food importer entities have officially registered as an FSVP importer. This list was last updated on March 7, 2018. The portal for that list is located here: https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm597095.htm Enforcement of the FSVP has begun! TAG has published a newsletter on this which can be found here: https://achesonfoodsafetyconsulting.com/single-post/2018/01/18/Second-Set-of-FSVP-Compliance-Dates-Looming The FDA is taking the position of “educate while they regulate mode.” As of March 13, 2018, here are the latest enforcement statistics: For Fiscal Year 2017: 0 Official Action Indicated, OAI, (0 Warning letters), 179 Voluntary Action Indicated, VAI, issued, (resulting in 174 483a issued), 106 No Action Indicated issued, NAI For Fiscal Year 2018: 0 OAI’s, 51 VAI’s (each with a 483a issued), 33 NAI’s There are six (6) major observations that FDA FSVP inspectors are finding: Failure to have an FSVP program. Failure to have a written Hazard Analysis per FSMA. Failure to have a written policy of only using approved foreign suppliers. Failure to document approval of foreign suppliers. Failure to document review and assessment of evaluation of risk of the food and supplier conducted by another entity. Incorrect entry data. FDA Investigators Update. Currently, the FDA has about 260 FDA investigators trained (or about to be trained) for FSVP compliance. The FDA has eight (8) FSVP “Train the Trainers”, with an additional eight (8) possible if funding allows. And finally, mis-use of the DUNS Number. This has occurred and when this happens, the FDA will not be holding companies accountable if they were falsely named but are going back to the filer for clarification. At TAG, we work with many clients on helping them understand the impact of FSMA compliance on their operations, understanding which rules apply to them, and the latest trends and updates. If your organization needs help discerning FSVP or other FSMA rules, and how to best implement within current programs – don’t hesitate to reach out to TAG! About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
