U.S. Food and Drug Administration Appoints Theodore P. Labuza as New Member of the Food Advisory Committee
Aug 18 15
The Institute of Food Technologists announced that IFT Past President Theodore P. Labuza, PhD has been appointed as a new member of the Food Advisory Committee of the FDA. IFT nominated Dr. Labuza for this position. Dr. Labuza is the Morse Alumni Distinguished Teaching Professor of Food Science and Engineering in the Department of Food Science and Nutrition at the University of Minnesota. Dr. Labuza will serve a term beginning immediately and ending June 30, 2019. In this capacity, he will provide advice to the Commissioner of Food and Drugs and other appropriate officials, on emerging food safety, food science, nutrition, and other food-related health issues that the FDA considers of primary importance for its food and cosmetics programs.
United States Food and Drug Administration Presents at UBS Genomics 2.0 Summit, Aug-13-2015 01:15 PM
Aug 10 15
United States Food and Drug Administration Presents at UBS Genomics 2.0 Summit, Aug-13-2015 01:15 PM. Venue: The St. Regis Deer Valley, Park City, Utah, United States. Speakers: David Litwack, Policy Advisor.
Alphatec Spine, Inc. Receives Warning Letter from U.S. Food and Drug Administration in Connection with the FDA's Inspection of the Company's Manufacturing Facilities Located in Carlsbad, CA
Jul 23 15
On July 17, 2015, Alphatec Spine, Inc. received a warning letter, dated July 16, 2015, from the U.S. Food and Drug Administration (FDA) in connection with the FDA's inspection of the company's manufacturing facilities located in Carlsbad, CA that occurred from February 4, 2015 until March 13, 2015. In the warning letter, the FDA cited eight deficiencies in the company's responses to the FDA Form 483, Inspectional Observations, which was issued to the company at the end of the Inspection. The deficiencies relate to the company's internal procedures for quality planning, design control, document control and corrective and preventive actions. The warning letter does not restrict production or shipment of the company's products from its facilities, or the sale or marketing of the company's products. The company is currently addressing the deficiencies cited by the FDA in the warning letter and intends to work closely with the FDA to resolve any outstanding issues. Until the procedures noted in the warning letter are corrected, the company may be subject to additional regulatory action by the FDA, and any such actions could significantly disrupt the company's ongoing business and operations and have a material adverse impact on the company's financial position and operating results.