EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
FDA Holds Public Meeting on PMTAs for Deemed Products Meeting Summary
FDLI Update November 26, 2019 https://www.fdli.org/2019/11/fda-holds-public-meeting-on-pmtas-for-deemed-products-meeting-summary/ Tara Lin Couch
Hitting FSMA Benchmarks in Warehousing and Distribution Networks
Food Safety Strategies November 15, 2019 https://www.foodsafetystrategies.com/articles/1049-hitting-fsma-benchmarks-in-warehousing-and-distribution-networks Purnendu Vasavada, Penny Vyskocil
Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters
Though FDA’s 21 CFR 111 GMPs for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance…
October 2019 Drug and Device Corner
REMINDER: we are currently in the renewal period (1 Oct – 31 Dec) for medical device & drug establishment registrations, as well as drug listing certifications. The FDA, in their commitment to assisting industry in the development of affordable, available, generic drugs, and as part of the...
Navigating CBP and Prior Notice of FDA’s Imported Products
As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of U.S. consumer and integrity of the food-based products being imported. FDA has historically seen an import rate increase of 5-10% in the last decade and in 2018, 31% of those were food products requiring prior notice.
Understanding how to navigate the FDA and US Customs import process, including how to utilize their programs to expedite the review of paperwork and shipments at the US ports of entry will be …
Why Safety Data Sheets Are Important for Safe Food Manufacturing Operations
Food Quality and Safety Magazine October 22, 2019 Robert Kapp
Equipment Sanitation May be Co-packer Liability
Gabe Miller, independent consultant and expert in equipment sanitation, published an article in Natural Products Insider on equipment sanitation and the need for co-packers to be aware of how this can impact their business – and liability. “Food processing equipment requires proper design,...
Couch Interviewed for Insider Podcast
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., was interviewed for a Natural Products Insider podcast on how important paper audits are to a contract lab qualification. Couch spoke at the SupplySide West show on this subject in a session titled: Trust in...
FDA Releases Plans for Draft Guidance on the Human Hazard Analysis and Risk-Based Preventive Control (HARPC) Rule – Chapter 14: Recall
FDA announced the release of the next chapter, in draft, of the Guidance for Industry "Hazard Analysis and Risk-Based Preventive Controls for Human Food" on recall plans. This newest chapter will assist the food industry establish and implement a written recall plan as required by 21 CFR 117.139....
FDA Publishes Required Records for FSVP
FDA has published a list of required records for foreign firms exporting food products for both animal and human consumption into the U.S. The Foreign Supplier Verification Program (FSVP), which is part of the Food Safety Modernization Act (FSMA), includes a number of additional requirements...
EAS Discusses Medical Device 510(k) Safety and Performance Measures in ISPE iSpeak Blog
Medical device manufacturers have a new tool available to demonstrate substantial equivalence through FDA’s 510(k) Safety and Performance measures. In a recently released Final Guidance, the Agency, as part of their effort towards stimulating innovation and reducing administrative burdens, all...
Sayler Interviewed for Article on Pathogens and Allergens in Food Safety Strategies
Allen Sayler was interviewed for an article published in Food Safety Strategies on preventing and testing for pathogens and allergens in the food industry including LIMs software and blockchain technologies and internal audits. With an increasing number of food recalls, staying vigilant with all...
Safe Foods for Canadians Act (SFCA) Discussed in Food Safety Magazine
EAS Independent Consultant, Ramakrishnan “Rama” Narasimhan published an article in Food Safety Magazine on the Safe Food for Canadians Act, including areas where it is similar to FDA’s FSMA. Did you know EAS offers food safety services for Canadian firms and has a number of Canadian independent...
Dietary Supplements and FSMA Compliance – Fallacy or Fact? – A Complimentary EAS Webinar
Do you know which of the seven major FSMA regulations were designed to support the Food Safety Modernization Act (FSMA)? Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior...
FDA’s Approach to Intentional Adulteration
Joe Famiglietti Each month EAS selects one question sent in by readers of EASeNews to answer as part of our Ask the Expert column. This month’s question on how FDA is enforcing Adulterated Foods is answered by Independent Consultant, Joe Famiglietti, who works closely with EAS clients in...
EAS offers QMS Services for Medical Devices
Quality Management Systems (QMS) for medical devices are cumbersome as layers upon layers of critical checks ensure the safety and effectiveness required for the consumer. However, in an effort to reduce overly burdensome recordkeeping processes FDA has announced a voluntary QMS switch from 21 CFR...
Safe Food for Canadians Act Regulations: An Overview
Food Safety Magazine October 15, 2019 https://www.foodsafetymagazine.com/enewsletter/safe-food-for-canadians-act-regulations-an-overview/ Ramakrishnan Narasimhan
Co-packer’s equipment may be liability to the brand
Natural Products Insider October 15, 2019 https://www.naturalproductsinsider.com/equipment/co-packers-equipment-may-be-liability-brand Gabe Miller
Co-Packer’s Equipment May be Liability to the Brand
Natural Products Insider October 15, 2019 https://www.naturalproductsinsider.com/equipment/co-packers-equipment-may-be-liability-brand Gabe Miller
Use of Safety and Performance to Determine Substantial Equivalence – FDA Issues New Guidance for Medical Devices
ISPE iSpeak blog October 7, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/use-safety-and-performance-determine-substantial-equivalence-fda Amy Scanlin
Preventing and Testing for Pathogens and Allergens Across the Food Industry
Food Safety Strategies October 4, 2019 https://www.foodsafetystrategies.com/articles/983-preventing-and-testing-for-pathogens-and-allergens-across-the-food-industry Allen Sayler
EAS Intern Publishes in FDLI Update Magazine
Neha Mookuparambil, a recent EAS intern focusing on pharmaceutical studies at Georgetown University published an article of FDA’s perspective on continuous manufacturing in FDLI Update, the bi-monthly magazine of the Food Drug Law Institute. EAS has partnered with Georgetown for a number of years...
Equipment and Utility Change Control for GMP Production Facilities
By Greg Weilersbacher Despite FDA’s guidance documents on change control, “…managing change to prevent unintended consequences,” many companies limit change control to documentation such as batch records, SOPs, protocols, and specifications and only sporadically evaluate that of equipment and...
Navigating CBP and Prior Notice of FDA’s Imported Products – October 29, 2019
As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of the U.S. consumer and integrity of the food-based products...
Menu Labeling
By Cathryn Sacra Each month EAS selects one question sent in by readers to be answered in EASeNews. This month’s answer is provided by Cathryn Sacra, Director of Labeling and Cosmetic Services. Cathryn oversees EAS’ labeling team, assisting clients with food and dietary supplement product labeling...
Cirotta Moderates Panel at FDLI Tobacco and Nicotine Product Regulation and Policy Conference
Dean Cirotta, President and COO, is moderating Multi-Stakeholder Reactor Panel at the FDLI 2019 Tobacco and Nicotine Product Regulation and Policy Conference at the National Press Club in DC October 24-25, 2019. The keynote speaker at this event is FDA’s Center for Tobacco Products Director...
EAS Offers OTC Labeling Review and Design in Compliance with FDA Monograph Regulations
Did you know that the current regulations for labeling of Over-the-Counter (OTC) drug products were initiated in 1972 as part of the OTC Drug Review? That’s over 50 years ago and the monograph system that arose from that process has not yet come to completion in terms of finalizing regulations for...
September 2019 Drug and Device Corner
The FDA has announced the Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality. This move is one critical component of the agency’s initiative to modernize the New Drugs Regulatory Program. The FDA...
Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters – November 7, 2019
Though FDA’s 21 CFR 111 Good Manufacturing Practices (GMPs) for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance. The establishment of specifications for components, in-process materials, and finished products; and then...
EAS to Exhibit at ISPE Annual Conference Focusing on Pharmaceuticals
Bryan Coleman, Senior Director for Drugs and Medical Devices, and Robert Fish, Independent Advisor for Quality and Compliance will be at the EAS booth, #524, at the International Society of Pharmaceutical Engineers Annual Meeting and Expo October 27-29, 2019 in Las Vegas. We invite you to stop by...