Tele: 561.316.3330
Breaking Medical Device News

Friday, October 15, 2021
HomeFDAFDA issues first injunction under Produce Safety Rule to Illinois-based Food Manufacturer...

FDA issues first injunction under Produce Safety Rule to Illinois-based Food Manufacturer for Repeated Food Safety Violations

September 15, 2020

The FDA (U.S. Food and Drug Administration) announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

FDA reports the action marks the first consent decree of permanent injunction against a firm or grower for violating public safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011. The Produce Safety Rule requires, among other things, that covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting; test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens; test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes; and take corrective actions when needed.

This action also follows several inspections conducted by the FDA, which found that the company failed to comply with Produce Safety and Current Good Manufacturing Practice regulations. In July 2018, the FDA sent a warning letter outlining food safety violations.

U.S. District Judge John Robert Blakey in the U.S. District Court for the Northern District of Illinois entered the consent decree of permanent injunction on September 15, 2020 between the U.S. and Fortune Food Product, Inc., its majority owner Steven Seeto and its supervisor Tiffany Jiang.

“Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk,” said FDA Chief Counsel Stacy Amin. “This action demonstrates the agency’s commitment to pursuing and taking swift action against those who repeatedly disregard these food safety standards and distribute adulterated foods.”

The consent decree prohibits the defendants from growing, harvesting, packing and holding sprouts and soy products at or from their facility, or any other facility, until certain requirements are met. The consent decree requires the defendants to, among other things, take corrective actions and notify the FDA before such operations may resume.

According to the complaint filed by the U.S. Department of Justice on behalf of the agency, the FDA conducted multiple inspections and documented insanitary conditions showing that sprouts and soy products may have become contaminated with filth or may have been rendered injurious to health.

The FDA is not aware of any confirmed illnesses related to Fortune Food’s products. However, consumers who think they may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report problems with this or any FDA-regulated product.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy