EAS Free Webinar: FSVP – FDA’s Number One FSMA Citation August 17, 2021 at 1PM ET
EAS is pleased to announce a complimentary webinar scheduled for August 17, 2021 on the Foreign Supplier Verification Program (FSVP)
FSVP – FDA’s Number One FSMA Citation
August 17, 2021 at 1pm eastern
Presented by EAS Independent Consultant, Carlos Ortiz
Did you know that FSMA requires an established FSVP that places the onus of compliance verification for all aspects of FSMA on the importers? Failure to meet FSVP requirements can jeopardize any food or food ingredient being imported into the US.FDA enforcement of FSVP is well underway and a review of FY2020 FDA 483s and Warning
Letters revealed many challenges with understanding and building a robust FSVP that meets FDA expectations. From suppliers to transporters of their products, every aspect of food safety assessment program must be documented – and the responsible party takes ownership of FSVP development and execution. What does this mean for you?
Join EAS independent Consultant, Carlos Ortiz, for a look at FSVP shortfalls through the eyes of FDA’s FY 2020 observations. Gain an understanding of FDA priorities, common pain points and steps to effectively create or strengthen your program.
About the Presenter:
Mr. Ortiz is a veteran FDA professional with over 20 years of Agency experience and a veteran of the US Air Force and Army. He served as Regional Activities Manager of the FDA’s Division of Import Operations for approximately ten years. In that role, he was responsible for reporting on the FDA’s import operations program and provided guidance to the field investigators in the Southeast Imports Division. He also served as a member of the Foreign Food Cadre and performed various GMP and HACCP inspections in Japan, China, Mexico, Germany, Ecuador, and India. Mr. Ortiz began his FDA career in 2002 as a field investigator in the Atlanta District specializing in imports and food inspections. In 2008 he transferred to the Center for Food Safety and Applied Nutrition as Compliance Officer.
About EAS Consulting Group:
EAS Consulting Group, a member of the Certified Group of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory
compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD.
Through our alignment with Certified Laboratories, a leading full-service food testing laboratory servicing the food industry since 1926 (certified-laboratories.com), Labstat, a best in class tobacco, nicotine and vape safety laboratory (labstat.com) and Labs-Mart, a dietary supplement, vitamin, and healthy products laboratory, (labs-mart.com), EAS can assist you with your regulatory requirements and challenges, while offering a more robust scope of testing services to meet your organization’s sophisticated needs.
From strategic product development, toxicology and microbiology assistance, preparation of technical submissions such as GRAS, Food Additive Petitions, DMFs, NDIs, 510(k)s and more; to FSMA compliance, expert witness services, due diligence assessments, or support after receipt of a FDA form 483 or Warning Letter, including market withdrawals, recalls and improvement plans with follow-on mock-FDA inspection audits, EAS offers the detailed knowledge and experience your company requires to ensure accurate and timely assistance. With our vast expertise in FDA’s policies and enforcement, EAS is the proven choice for assistance with FDA, product testing and other regulatory solutions. easconsultinggroup.com