Warnings, Earnings, Racing: Health And Wellness Industry News

摘要

Armada Nutrition response on 483 observations inadequate; Herbalife 'entering new chapter'; Mannatech turns around from year-ago loss; and Prevagen goes racing. Armada Nut rit ion LLC's response to FDA that it was establishing procedures for ingredient identity and equipment testing and had established contamination-prevention procedures did not deter the agency from submitting a warning letter for dietary supplement good manufacturing practices violations. During an inspection at the Spring Hill, Tenn., firm's facility in March, Office of Regulatory Affairs Cincinnati District officials noted form 483 observations including failing to establish and maintain standard operating procedures for identity testing on incoming ingredients, in-process materials and finished products and for calibrating instruments and controls used in those tests since beginning operations in July 2016. The inspectors also observed employees failing to follow procedures to prevent contamination of equipment and products or ingredients during cleaning operations, according to the Aug. 1 warning. The firm's April 13 response to the form 483 stated procedures for ingredient and equipment testing would be established by Oct. 1, but “did not provide documentation regarding how [it] will ensure the adequate laboratory operations in the meantime” nor documentation on its contamination-prevention processes, ORA said in its 50 warning letter to supplement industry firms so far in 2017 . th